Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

Not Applicable

Recruiting

• Conditions: Glaucoma

• Registration Number: NCT05797350
• Lead Sponsor: Al Watany Eye Hospital

Brief Summary

A randomized controlled trial comparing the efficacy and safety of Paul glaucoma implant and Ahmed glaucoma valve in refractory childhood glaucoma patients

Detailed Description

A prospective randomized controlled trial was conducted at Al Watany Eye Hospital in Egypt. Patients with refractory primary or secondary childhood glaucoma who glaucoma specialist has decided to perform a tube implant to control their intraocular pressure are randomized to receive either Paul or Ahmed glaucoma drainage devices.

Patients will be followed up for at least one year during which the following data are collected.

Age, sex, laterality, preoperative and postoperative intraocular pressure and glaucoma medications at 1,3,6, 9, and 12 months visits. Any intraoperative or postoperative complications will be recorded

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-03-12
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-02
• Last Update Submitted: 2023-04-02
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Childhood glaucoma patients (whether primary or secondary) including Juvenile open angle glaucoma if the age at the time of surgery was ≤18 years.
• The included patients are those with refractory glaucoma who require a tube to control their intraocular pressure.

Exclusion Criteria

• Any patient with incomplete data or has a follow-up less than 1 year will be excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IOP Reduction	1 year	More than 20% change from baseline without development of vision threatening complications

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	1 year
Glaucoma Medication Alterations	1 year	Assessment of changes in number of medications for IOP reduction after procedure (i.e., did patients have a reduction or gain in use of medications to reduce their IOP after the procedure?)

Trial Locations

Locations (1)

Maadi eye subspeciality center; 🇪🇬 Cairo, Egypt