Surgery for Primary Congenital Glaucoma in Neonates

Surgery for Primary Congenital Glaucoma in Neonates:Randomized Controlled Study.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Congenital Glaucoma
• Intervention / Treatment: Procedure: viscotrabeculotomy (VT); Procedure: visco-circumferential-suture-trabeculotomy (VCST) .; Procedure: combined VT-Trabeculectomy with MMC (VT-Trab).

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amr M Mohammed, MD; Phone Number: +20 1004314242; Email: dramrabdelkader@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Primary Congenital Glaucoma in Neonates

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: viscotrabeculotomy (VT)).	Procedure: viscotrabeculotomy (VT); viscotrabeculotomy (VT)
Active Comparator: visco-circumferential-suture-trabeculotomy (VCST)	Procedure: visco-circumferential-suture-trabeculotomy (VCST) .; visco-circumferential-suture-trabeculotomy (VCST)
Active Comparator: Combined VT-Trabeculectomy with MMC (VT-Trab).	Procedure: combined VT-Trabeculectomy with MMC (VT-Trab).; combined VT-Trabeculectomy with MMC (VT-Trab).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate in lowering intraocular pressure (IOP)	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.	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: January 9, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Glaucoma, Open-Angle; Infant, Newborn, Diseases; Glaucoma; Hydrophthalmos
• Other Study ID Numbers: Viscotrabeculotomy VI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: providing data as supplemental digital content
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No