Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT05401760
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2022-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006871', 'term': 'Hydrophthalmos'}], 'ancestors': [{'id': 'D005124', 'term': 'Eye Abnormalities'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Inclusion criteria:\n\n1. Patients with pediatric congenital cataract Aged less than two years associated with other ocular anomalies which is high risk for developing PCSG as microcornea and aniridia.\n2. Patient with pediatric cataract with other eye had post cataract surgery glaucoma'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-03', 'studyFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure', 'timeFrame': 'up to one year follow up', 'description': 'glaucoma'}], 'secondaryOutcomes': [{'measure': 'rate of complications', 'timeFrame': 'one year follow up', 'description': 'hyphaema or intraocular inflammation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Glaucoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to report the effectiveness of phacoaspiration when combined with angle surgery in preventing postoperative glaucoma following pediatric cataract surgery', 'detailedDescription': 'As postoperative glaucoma could be the consequence of a dysgenesis of the iridocorneal angle that accompanies the dysgenesis of the lens so, the hypothesis states that combined phacoaspiration with angle surgery may be superior to phacoaspiration as standalone procedure in controlling IOP within the normal range postoperatively after pediatric cataract surgery\n\n• Patients with pediatric cataract will be subdivided into 2 groups: Group A: includes eyes for whom combined phacoaspiration \\& angle surgery will be done.\n\nGroup B: includes eyes for whom phacoaspiration only will be done. All surgeries will be performed in Mansoura Ophthalmic Center by the same surgeon or under his supervision.\n\nPreoperative:\n\n1. History: Full ocular \\& general history will be taken Ocular history: history of ocular trauma, ocular surgeries \\& wearing glasses. General medical history: age, history of any associated neurologic, metabolic or systemic disease or drug intake.\n2. Examination: Full ocular examination will be done\n\n * Anterior segment examination using (Topcon or Zeiss surgical microscopes) or (Zeiss or hag streit slit lamps).\n * Corneal diameter will be measured.\n * Fundus examination using indirect ophthalmoscope (KEELER Vantage Plus indirect ophthalmoscope) if the fundus is visible.\n * IOP measuring using Schoitz tonometer.\n * Refraction (if the eye can be refracted) \\& K readings will be measured using portable autorefractometer (Retinomax K-plus2).\n3. Investigations:\n\n * Axial length, anterior chamber depth \\& Ocular biometry will be measured using (Nidek Al-Scan Optical Biometer).\n * B-scan will be done using (Nidek Us-4000 Echoscan).\n * Ultrasound biomicroscopy (UBM) scan will be performed using (VuMAX HD).\n\nIntraoperative:\n\n1. Group A: for whom combined phacoaspiration \\& angle surgery ither trabeculotomy will be done. I\n\n * Partial thickness scleral flap to access the canal of schlemm.\n * 2 side ports will be fashioned.\n * Trypan blue will be injected to aid visualization of the anterior capsule \\& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.\n * The nucleus and cortex will be aspirated.\n * Posterior capsulrehxis and limited anterior vitrectomy will be done.\n * Corneal incisions will be sutured with 10-0 Nylon suture.\n * Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm.\n * Suturing of scleral flap with 10-0 Nylon suture.\n2. Group B: for whom phacoaspiration only will be done.\n\n * 2 side ports will be fashioned.\n * Trypan blue will be injected to aid visualization of the anterior capsule \\& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.\n * The nucleus and cortex will be aspirated.\n * Posterior capsulrehxis and limited anterior vitrectomy will be done.\n * Corneal incisions will be sutured with 10-0 Nylon suture.\n\nPostoperative:\n\n1. All patients will be discharged on:\n\n * Systemic \\&topical antibiotic eye drops.\n * Topical steroids.\n * Cycloplegic eye drops.\n * Combined antibiotic and steroid eye ointment.\n2. Topical Steroids \\& cycloplegic eye drops will be gradually withdrawn over a period of 3 months.\n3. The eyes will be carefully examined at each follow-up visit (1 week, 2 weeks 1months and 3 months).\n4. During each visit:\n\n * Anterior segment examination will be done.\n * Measuring of:\n\n * Corneal diameter.\n * Cup/disc ratio.\n * IOP using Schoitz tonometer.\n * Axial length, anterior chamber depth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* pediatric congenital cataract Aged less than two years associated with other ocular anomalies which is high risk for developing glaucoma as microcornea and aniridia.\n* pediatric cataract with other eye had post cataract surgery glaucoma\n\nExclusion criteria:\n\n* Acquired cataracts secondary to trauma or uveitis.\n* Aged more than two years.\n* Associated corneal opacities.'}, 'identificationModule': {'nctId': 'NCT05401760', 'briefTitle': 'Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract', 'orgStudyIdInfo': {'id': 'R.22.05.1718'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done.', 'description': 'Group A: for whom combined phacoaspiration \\& angle surgery trabeculotomy will be done.\n\n* continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.\n* The nucleus and cortex will be aspirated.\n* Posterior capsulrehxis and limited anterior vitrectomy will be done.\n* Corneal incisions will be sutured with 10-0 Nylon suture.\n* Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm.\n* Suturing of scleral flap with 10-0 Nylon suture.', 'interventionNames': ['Procedure: Group A :combined phacoaspiration and angle surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B : includes eyes with only phacoaspiration will be done', 'description': 'Group B: for whom phacoaspiration only will be done.\n\n* 2 side ports will be fashioned.\n* Trypan blue will be injected to aid visualization of the anterior capsule \\& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.\n* The nucleus and cortex will be aspirated.\n* Posterior capsulrehxis and limited anterior vitrectomy will be done.\n* Corneal incisions will be sutured with 10-0 Nylon suture.', 'interventionNames': ['Procedure: Group B : phacoaspiration only']}], 'interventions': [{'name': 'Group A :combined phacoaspiration and angle surgery', 'type': 'PROCEDURE', 'description': '* Partial thickness scleral flap to access the canal of schlemm.\n* 2 side ports will be fashioned.\n* Trypan blue will be injected to aid visualization of the anterior capsule \\& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.\n* The nucleus and cortex will be aspirated.\n* Posterior capsulrehxis and limited anterior vitrectomy will be done.\n* Corneal incisions will be sutured with 10-0 Nylon suture.\n* Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm.\n* Suturing of scleral flap with 10-0 Nylon suture.', 'armGroupLabels': ['Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done.']}, {'name': 'Group B : phacoaspiration only', 'type': 'PROCEDURE', 'description': '* 2 side ports will be fashioned.\n* Trypan blue will be injected to aid visualization of the anterior capsule \\& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.\n* The nucleus and cortex will be aspirated.\n* Posterior capsulrehxis and limited anterior vitrectomy will be done.\n* Corneal incisions will be sutured with 10-0 Nylon suture.', 'armGroupLabels': ['Group B : includes eyes with only phacoaspiration will be done']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Dina Abd Elfattah', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'results of collected data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of ophthalmology Mansoura University', 'investigatorFullName': 'Dina abdelfattah', 'investigatorAffiliation': 'Mansoura University'}}}}