Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-03-01
2023-07-01
Brief Summary
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Detailed Description
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The primary outcome of this study is compare the success rate in lowering IOP between the 3 surgical options in infants with Primary Congenital Glaucoma (PCG) below 1 month of age. The secondary clinical outcomes will include Intraocular pressure (IOP), horizontal corneal diameter, axial length, cup-disc ratio, refractive error and postoperative complications in these 3 surgical procedures. Data will be analysed. Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without antiglaucoma drugs (AGD) or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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viscotrabeculotomy (VT)).
viscotrabeculotomy (VT)
viscotrabeculotomy (VT)
visco-circumferential-suture-trabeculotomy (VCST)
visco-circumferential-suture-trabeculotomy (VCST) .
visco-circumferential-suture-trabeculotomy (VCST)
Combined VT-Trabeculectomy with MMC (VT-Trab).
combined VT-Trabeculectomy with MMC (VT-Trab).
combined VT-Trabeculectomy with MMC (VT-Trab).
Interventions
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viscotrabeculotomy (VT)
viscotrabeculotomy (VT)
visco-circumferential-suture-trabeculotomy (VCST) .
visco-circumferential-suture-trabeculotomy (VCST)
combined VT-Trabeculectomy with MMC (VT-Trab).
combined VT-Trabeculectomy with MMC (VT-Trab).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
30 Days
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Amr Mohammed Elsayed Abdelkader
Lecturer of ophthalmology
Central Contacts
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Other Identifiers
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Viscotrabeculotomy VI
Identifier Type: -
Identifier Source: org_study_id
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