Surgery for Primary Congenital Glaucoma in Neonates

Mansoura University

Status: Unknown

Conditions: Primary Congenital Glaucoma

Treatments: Procedure: viscotrabeculotomy (VT); Procedure: combined VT-Trabeculectomy with MMC (VT-Trab).; Procedure: visco-circumferential-suture-trabeculotomy (VCST) .

Study type: Interventional

Funder types: Other

Identifiers

NCT04709497

Viscotrabeculotomy VI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

Primary Congenital Glaucoma in Neonates

Exclusion criteria

secondary Congenital Glaucoma in Neonates. Congenital Glaucoma presented after 1 month of age.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

viscotrabeculotomy (VT)).

Active Comparator group

Treatment:

Procedure: viscotrabeculotomy (VT)

visco-circumferential-suture-trabeculotomy (VCST)

Active Comparator group

Treatment:

Procedure: visco-circumferential-suture-trabeculotomy (VCST) .

Combined VT-Trabeculectomy with MMC (VT-Trab).

Active Comparator group

Treatment:

Procedure: combined VT-Trabeculectomy with MMC (VT-Trab).