Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-02 @ 2:47 AM
Study NCT ID:
NCT05771467
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2023-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ysf20smt@gmail.com', 'phone': '+0905069228431', 'title': 'Dr. Aslı Cetinkaya Yaprak', 'organization': 'AkdenizU'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury\n\nOptical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry: Ophthalmologic Examination Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nOptical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry: Ophthalmologic Examination Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Corneal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury\n\nOptical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry: Ophthalmologic Examination Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nOptical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry: Ophthalmologic Examination Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)'}, {'id': 'OG002', 'title': 'Total Group', 'description': 'Total number of cases'}], 'classes': [{'categories': [{'measurements': [{'value': '542.23', 'spread': '27.47', 'groupId': 'OG000'}, {'value': '546.16', 'spread': '46.03', 'groupId': 'OG001'}, {'value': '544.32', 'spread': '35.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Corneal thickness in mikrometer value', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Chamber Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-trauma eye after open globe injury determine retinal microvascular changes\n\nComprehensive Ophthalmologic Examination: Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Investigation of retinal microvascular circulation in age- and sex-matched healthy volunteers\n\nComprehensive Ophthalmologic Examination: Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)'}], 'classes': [{'categories': [{'measurements': [{'value': '177.97', 'spread': '28.46', 'groupId': 'OG000'}, {'value': '165.9', 'spread': '26.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Anterior chamber volume in mm3', 'unitOfMeasure': 'Cubic micrometre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Chamber Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-trauma eye after open globe injury determine retinal microvascular changes\n\nComprehensive Ophthalmologic Examination: Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Investigation of retinal microvascular circulation in age- and sex-matched healthy volunteers\n\nComprehensive Ophthalmologic Examination: Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.93', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.05', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Anterior chamber depth in mm', 'unitOfMeasure': 'milimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anterior Chamber Angle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nAll subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.87', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '4.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Anterior chamber angle in degree', 'unitOfMeasure': 'degree', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Power', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nAll subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.98', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '20.26', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'in diopters', 'unitOfMeasure': 'diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Steep Keratometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nAll subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.22', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '44.57', 'spread': '1.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'in Diopters measured with pentacam', 'unitOfMeasure': 'diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tonometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nAll subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.74', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '15.78', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Intraocular pressure measurement in mmHg', 'unitOfMeasure': 'milimeter mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Axial Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nAll subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.86', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '23.36', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Axial length in mm', 'unitOfMeasure': 'milimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Optic Nerve Head Vessel Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nAll subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.22', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Optic nerve head vessel density assessed with optical coherence tomography angiography', 'unitOfMeasure': 'vessels/mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Choriocapillaris Flow Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nAll subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.88', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '36.53', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Choriocapillaris flow area assessed with optical coherence tomography angiography', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subfoveal Central Macular Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nAll subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.'}], 'classes': [{'categories': [{'measurements': [{'value': '321.42', 'spread': '24.52', 'groupId': 'OG000'}, {'value': '311.57', 'spread': '31.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Subfoveal central macular thickness assessed with optical coherence tomography', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury All subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded. The patients were followed for approximately six months, examined at one week, one month and three months after the trauma, and a total of three measurements were taken from the subjects.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nAll subjects underwent a comprehensive ophthalmologic examination, which included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and retinal and choroidal thickness and microvascular circulation of the retina and choroid were measured and recorded with Swept-Source Optical Coherence Tomography Angio™ (Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle resolution (logMAR). Of the individuals included in the study, anterior chamber depth (ACD), anterior chamber volume (ACV), thinnest corneal thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation (SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were recorded.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trauma Group', 'description': 'Non-Trauma Eye After Open-Globe Injury\n\nOptical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry: Ophthalmologic Examination Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Age-, sex-matched healthy volunteers\n\nOptical Coherence Tomography Angiography (OCTA) • Biometry • Auto refractometry • Non contact tonometry: Ophthalmologic Examination Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '20.6', 'groupId': 'BG000'}, {'value': '43', 'spread': '17.5', 'groupId': 'BG001'}, {'value': '44', 'spread': '19.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'older 18 years'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-27', 'size': 324362, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-27T14:03', 'hasProtocol': True}, {'date': '2023-11-27', 'size': 222472, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-27T14:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2023-03-06', 'resultsFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-27', 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Thickness', 'timeFrame': '10 minutes', 'description': 'Corneal thickness in mikrometer value'}, {'measure': 'Anterior Chamber Volume', 'timeFrame': '10 minutes', 'description': 'Anterior chamber volume in mm3'}, {'measure': 'Anterior Chamber Depth', 'timeFrame': '10 minutes', 'description': 'Anterior chamber depth in mm'}, {'measure': 'Anterior Chamber Angle', 'timeFrame': '10 minutes', 'description': 'Anterior chamber angle in degree'}, {'measure': 'Lens Power', 'timeFrame': '10 minutes', 'description': 'in diopters'}, {'measure': 'Steep Keratometry', 'timeFrame': '10 minutes', 'description': 'in Diopters measured with pentacam'}, {'measure': 'Tonometry', 'timeFrame': '10 minutes', 'description': 'Intraocular pressure measurement in mmHg'}, {'measure': 'Axial Length', 'timeFrame': '10 minutes', 'description': 'Axial length in mm'}, {'measure': 'Optic Nerve Head Vessel Density', 'timeFrame': '10 minutes', 'description': 'Optic nerve head vessel density assessed with optical coherence tomography angiography'}, {'measure': 'Choriocapillaris Flow Area', 'timeFrame': '10 minutes', 'description': 'Choriocapillaris flow area assessed with optical coherence tomography angiography'}, {'measure': 'Subfoveal Central Macular Thickness', 'timeFrame': '10 minutes', 'description': 'Subfoveal central macular thickness assessed with optical coherence tomography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eye Injury Trauma', 'Open Globe Injury', 'Optical Coherence Tomography'], 'conditions': ['Eye Injury Trauma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate posterior segment changes in the non-traumatic eye after open globe injury.', 'detailedDescription': 'Globe injuries can be classified as either closed- or open-globe injuries, based on the integrity of the sclera and cornea. Open-globe injury (OGI) is characterized by a full-thickness wound of the ocular wall.\n\nAs one of the most severe forms of ocular trauma, open-globe injury (OGI) causes significant vision loss. Timely and meticulous repair of these injuries can improve patient outcomes.\n\nOGI by rupture often occurs at the weakest point of the eye wall, which may or may not be at the actual injury site. The rupture site is most commonly found in the sclera concentric to the limbus, just posterior to the insertion of the extraocular muscles.\n\nAfter trauma, changes may occur in the non-trauma eye. Retinal and choroidal circulation may change as a result of adaptation mechanisms. In this study, we evaluated the vascular densities of the control group and post-traumatic non-trauma eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Middle age, predominantly male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be over 18 years old\n* Unilateral eye injury\n\nExclusion Criteria:\n\n* Be under the age of 18\n* Usage of systemic drugs or topical ocular drops\n* Bilateral eye injury\n* Having systemic disease, having ocular pathology that may decrease visual acuity'}, 'identificationModule': {'nctId': 'NCT05771467', 'briefTitle': 'Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury With Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'AKDENIZ-GOZ-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trauma Group', 'description': 'Non-trauma eye after open globe injury determine retinal microvascular changes', 'interventionNames': ['Diagnostic Test: Comprehensive Ophthalmologic Examination']}, {'label': 'Control Group', 'description': 'Investigation of retinal microvascular circulation in age- and sex-matched healthy volunteers', 'interventionNames': ['Diagnostic Test: Comprehensive Ophthalmologic Examination']}], 'interventions': [{'name': 'Comprehensive Ophthalmologic Examination', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Optical Coherence Tomography Angiography (OCTA)', 'Biometry', 'Auto refractometry', 'Non contact tonometry'], 'description': 'Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters, optical coherence tomography angiography (OCTA)', 'armGroupLabels': ['Control Group', 'Trauma Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '070059', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Aslı Çentinkaya Yaprak', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'zip': '07070', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Yusuf Samet Atlıhan', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Yusuf Samet Atlıhan, MD, 1', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akdeniz University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Aslı Çetinkaya Yaprak', 'investigatorAffiliation': 'Akdeniz University'}}}}