Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-29 @ 11:05 AM
Study NCT ID:
NCT05014269
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2021-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phacoemulsification in Patients With Corneal Opacities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003318', 'term': 'Corneal Opacity'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}, {'id': 'D014785', 'term': 'Vision, Ocular'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}, {'id': 'D055537', 'term': 'Light Signal Transduction'}, {'id': 'D015398', 'term': 'Signal Transduction'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009799', 'term': 'Ocular Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of intra-operative complications of phacoemulsification in eyes with corneal opacities using the slit ilumination of the surgical microscope.', 'timeFrame': '3 months', 'description': 'the frequency of the intraoperative complications of phacoemulsification in eyes with corneal opacities'}], 'secondaryOutcomes': [{'measure': 'Visual outcome of phacoemulsification in eyes with corneal opacities', 'timeFrame': '3 months', 'description': 'meaurement of the change of the distance corrected visual acuity bafoer after phacoemulsification using Snellen chart'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Senile Cataract', 'Corneal opacity', 'Phacoemulsification'], 'conditions': ['Senile Cataract']}, 'descriptionModule': {'briefSummary': 'In this retrospective case series, the feasibility of performing phacoemulsification using slit illumination in eyes with corneal opacity was assessed.', 'detailedDescription': 'Corneal opacity is often encountered in patients seeking senile cataract surgery in developing countries. Corneal opacity impairs the intraoperative visualization during cataract surgery which increases the risk of copmlications.\n\nSeveral techniques were described to enhance the intraoperative visualization such as the use of anterior endoscopy, chandeiler retroillumination, and anterior chamber endoillumination. All these techniques require costly instrumentation.\n\nthe aim of this study was to assess the feasibility of performing phacoemulsification using slit illumination of the surgical microscope without the need of additional instruments, and report the visual outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with visually significant senile cataract and corneal opacities', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* The presence of visually significant senile cataract.\n* A recent history of progressive diminution of vision within few months.\n* Stable density and size of a preexisting trachomatous corneal opacity that does not impair the pupil or lens visualization after pupillary dilatation.\n\nExclusion Criteria:\n\n* History of trauma, infectious corneal ulcers, or intraocular surgery.\n* Coexisting ocular diseases e.g. glaucoma, retinal detachment, and vitreous hemorrhage.'}, 'identificationModule': {'nctId': 'NCT05014269', 'briefTitle': 'Phacoemulsification in Patients With Corneal Opacities', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Phacoemulsification in Patients With Corneal Opacities Using Slit Illumination of the Surgical Microscope', 'orgStudyIdInfo': {'id': 'phacoemulsification surgery'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Phacoemulsification in eyes with corneal opacities', 'type': 'PROCEDURE', 'description': 'senile cataract extraction using lens emulsification under the slit illuimnation of the surgical microscope'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Ophthalmology', 'investigatorFullName': 'Mahmoud F. Rateb', 'investigatorAffiliation': 'Assiut University'}}}}