Surgery for Primary Congenital Glaucoma in Neonates

Not Applicable

• Conditions: Primary Congenital Glaucoma
• Interventions: Procedure: viscotrabeculotomy (VT); Procedure: combined VT-Trabeculectomy with MMC (VT-Trab).; Procedure: visco-circumferential-suture-trabeculotomy (VCST) .

• Registration Number: NCT04709497
• Lead Sponsor: Mansoura University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-09
• Study First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-14
• Study Start: 2021-03-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Primary Congenital Glaucoma in Neonates

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
viscotrabeculotomy (VT)).	viscotrabeculotomy (VT)	-
Combined VT-Trabeculectomy with MMC (VT-Trab).	combined VT-Trabeculectomy with MMC (VT-Trab).	-
visco-circumferential-suture-trabeculotomy (VCST)	visco-circumferential-suture-trabeculotomy (VCST) .	-

Primary Outcome Measures

Name	Time	Method
success rate in lowering intraocular pressure (IOP)	3 years	Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without 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.

Secondary Outcome Measures

Name	Time	Method
horizontal corneal diameter	3 years	The change in "white to white" corneal diameters in mm measured by caliber.
refractive error	3 years	The change in refractive error as measured by autorefractometer..
axial length	3 years	The change in axial length in mm measured by ultrasonography.
cup-disc ratio	3 years	The change in cup -disc ratio as measured by optical coherence tomography.