Trials / Unknown
UnknownNCT04709497
Surgery for Primary Congenital Glaucoma in Neonates
Surgery for Primary Congenital Glaucoma in Neonates:Randomized Controlled Study.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Mansoura University · Academic / Other
- Sex
- All
- Age
- 1 Day – 30 Days
- Healthy volunteers
- Not accepted
Summary
The current study aimed to compare between the long-term surgical outcomes of 3 surgical options (viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab) in treatment of infants with (Primary Congenital Glaucoma (PCG)) below 1 month of age.
Detailed description
This is a prospective, randomised controlled trial. We plan to recruit 60 infants with primary congenital glaucoma and younger than 1 month of age at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt. Eyes will be randomly assigned to undergo one of 3 surgical interventions: viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab). 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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | viscotrabeculotomy (VT) | viscotrabeculotomy (VT) |
| PROCEDURE | visco-circumferential-suture-trabeculotomy (VCST) . | visco-circumferential-suture-trabeculotomy (VCST) |
| PROCEDURE | combined VT-Trabeculectomy with MMC (VT-Trab). | combined VT-Trabeculectomy with MMC (VT-Trab). |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2023-03-01
- Completion
- 2023-07-01
- First posted
- 2021-01-14
- Last updated
- 2021-01-14
Source: ClinicalTrials.gov record NCT04709497. Inclusion in this directory is not an endorsement.