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Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery

NCT05011747 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-18

No results posted yet for this study

Summary

Long term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery.

Purpose:

This study aims to compare outcomes of single-site rigid probe viscotrabeculotomy (VT) to two-site VT in pediatric secondary glaucoma following cataract surgery.

Methods:

This is a comparative study was performed on patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation. Eyes in which the trabeculotomy involves \<180° of Schlemm's canal ,eyes that have synechial angle closure over ≥ 90° and eyes that have previous procedures other than lensectomy or IOL implantation are excluded from the study. Eyes are then randomized to undergo single-site VT or two-site VT using a random table. The two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap. Intraocular pressure (IOP), anti-glaucoma medications, complications and success rates at dates of follow up are all reported. Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery.

Conditions

  • Glaucoma Congenital

Interventions

PROCEDURE

single-site rigid probe viscotrabeculotomy (VT)

single-site VT by the rigid probe trabeculotome is performed through a superonasal triangular scleral flap.

PROCEDURE

two-site rigid probe viscotrabeculotomy (VT)

Two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2024-09-30
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05011747 on ClinicalTrials.gov