Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-03 @ 10:44 AM
Study NCT ID:
NCT04957459
Status:
UNKNOWN
Last Update Posted:
2021-07-12
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-30', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macular hole status', 'timeFrame': 'at 1 month after surgery', 'description': 'macular hole status (open, flat open or closed)'}, {'measure': 'MLD of macular hole', 'timeFrame': 'Before surgery', 'description': 'Calculation of minimum liner diameter of macular hole with optical coherence tomography angiography'}, {'measure': 'BD of macular hole', 'timeFrame': 'Before surgery', 'description': 'Calculation of base diameter of macular hole with optical coherence tomography angiography'}, {'measure': 'Choroidal hypertransmission width of macular hole', 'timeFrame': 'Before surgery', 'description': 'Calculation of Choroidal hypertransmission width of macular hole with optical coherence tomography angiography'}, {'measure': 'Horizontal ellipsoid band missing diameter of macular hole', 'timeFrame': 'Before surgery', 'description': 'Calculation of Horizontal ellipsoid band missing diameter of macular hole with optical coherence tomography angiography'}, {'measure': 'Baseline best-corrected visual acuity', 'timeFrame': 'Before surgery', 'description': 'best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis'}, {'measure': 'best-corrected visual acuity at 1 month', 'timeFrame': 'at 1 month after surgery', 'description': 'best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis'}, {'measure': 'best-corrected visual acuity at 2 months', 'timeFrame': 'at 2 months after surgery', 'description': 'best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis'}, {'measure': 'best-corrected visual acuity at 3 months', 'timeFrame': 'at 3 months after surgery', 'description': 'best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis'}, {'measure': 'best-corrected visual acuity at 4 months', 'timeFrame': 'at 4 months after surgery', 'description': 'best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis'}, {'measure': 'best-corrected visual acuity at 5 months', 'timeFrame': 'at 5 months after surgery', 'description': 'best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis'}, {'measure': 'best-corrected visual acuity at 6 months', 'timeFrame': 'at 6 months after surgery', 'description': 'best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis'}, {'measure': 'FAZ area of macular hole', 'timeFrame': 'Before surgery', 'description': 'Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography'}, {'measure': 'FAZ area of macular hole at 1 month', 'timeFrame': 'at 1 month after surgery', 'description': 'Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography'}, {'measure': 'FAZ area of macular hole at 2 months', 'timeFrame': 'at 2 months after surgery', 'description': 'Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography'}, {'measure': 'FAZ area of macular hole at 3 months', 'timeFrame': 'at 3 months after surgery', 'description': 'Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography'}, {'measure': 'FAZ area of macular hole at 4 months', 'timeFrame': 'at 4 months after surgery', 'description': 'Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography'}, {'measure': 'FAZ area of macular hole at 5 months', 'timeFrame': 'at 5 months after surgery', 'description': 'Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography'}, {'measure': 'FAZ area of macular hole at 6 months', 'timeFrame': 'at 6 months after surgery', 'description': 'Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography'}, {'measure': 'CRT of macular hole', 'timeFrame': 'Before surgery', 'description': 'Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography'}, {'measure': 'CRT of macular hole at 1 month', 'timeFrame': 'at 1 month after surgery', 'description': 'Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography'}, {'measure': 'CRT of macular hole at 2 months', 'timeFrame': 'at 2 months after surgery', 'description': 'Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography'}, {'measure': 'CRT of macular hole at 3 months', 'timeFrame': 'at 3 months after surgery', 'description': 'Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography'}, {'measure': 'CRT of macular hole at 4 months', 'timeFrame': 'at 4 months after surgery', 'description': 'Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography'}, {'measure': 'CRT of macular hole at 5 months', 'timeFrame': 'at 5 months after surgery', 'description': 'Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography'}, {'measure': 'CRT of macular hole at 6 months', 'timeFrame': 'at 6 months after surgery', 'description': 'Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['idiopathic full thickness macular hole', 'OCTA', 'postoperative best corrected visual acuity', 'vitrectomy'], 'conditions': ['Macular Holes']}, 'descriptionModule': {'briefSummary': "This study retrospectively analyzed the relationship between the preoperative optical coherence tomography(OCT) and optical coherence tomography angiography(OCTA) software related parameters of patients with idiopathic macular hole, the patient's own clinical data and the best corrected visual acuity (BCVA) for at least one month after surgery.", 'detailedDescription': 'After Pars plana vitrectomy combined with removal of the internal limiting membrane (ILM) and air filling, it can not only promote the closure of the macular hole in patients with idiopathic macular hole, but also improve the visual acuity of the affected eye. There are various studies to predict the visual acuity of patients after surgery recovery, but due to many factors that affect the effect of macular hole surgery, the improvement of visual acuity after retinal surgery varies greatly in different eyes. As a new type of ophthalmology device, OCTA plays an important role in measuring the size of the hole and the changes of retinal capillaries. Therefore, this study intends to calculate patient parameters based on OCT and OCTA equipment. Statistical software was used to analyze the relationship between each parameter and the best corrected visual acuity (BCVA) for at least one month after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with idiopathic macular hole after vitrectomy combined with internal limiting membrane peeling and air-filling surgery and the MH is closed and the postoperative best corrected visual acuity is at least 1 month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* idiopathic MHs, the MH is closed ,and follow-up for at least 1 month after vitrectomy.\n\nExclusion Criteria:\n\n* High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, \\>21 mm Hg) or glaucoma, severe cataract, severe corneal disease，severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery'}, 'identificationModule': {'nctId': 'NCT04957459', 'briefTitle': 'The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Prospective, Observational,Non-interventional Research of The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes', 'orgStudyIdInfo': {'id': 'I2021001380'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiyong Zhang, docter', 'role': 'CONTACT', 'email': 'zhangziyongnet@163.com', 'phone': '13968059392'}], 'facility': 'Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Zhiyong Zhang, docter', 'role': 'CONTACT', 'email': 'zhangziyongnet@163.com', 'phone': '13968059392'}], 'overallOfficials': [{'name': 'Qi Wan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}