Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Device: Glaucoma Drainage Device

• 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

Arm && Interventions

Group	Intervention	Description
Paul Glaucoma Implant	Glaucoma Drainage Device	The Paul glaucoma implant (PGI) will be used as an active comparator group to compare its effectiveness and safety with the Ahmed glaucoma valve in the treatment of childhood glaucoma. The PGI works by diverting excess fluid from the eye to a plate placed under the conjunctiva, which allows the fluid to drain away from the eye and be absorbed. This helps to lower the pressure inside the eye, which is important for preventing vision loss and other complications associated with glaucoma. The PGI has a smaller internal and external tube diameter than the Ahmed glaucoma valve, which reduces the contact area between the tube and the corneal endothelium. This theoretically reduces the rate of endothelial cell loss, which can be a complication of GDDs. Additionally, the extraocular portion of the PGI is smaller, which may reduce the long-term risk of tube erosion and exposure. The smaller lumen may theoretically reduce the risk of postoperative hypotony as well.
Ahmed Glaucoma valve	Glaucoma Drainage Device	The Ahmed glaucoma valve (AGV) arm of the study is the active comparator group and is intended to be directly compared to the Paul glaucoma implant (PGI) in treating childhood glaucoma. The AGV is a type of glaucoma drainage device that is designed to lower intraocular pressure in patients with refractory glaucoma. It is made of a rigid plastic material and consists of a small drainage tube that is inserted into the eye and a valve mechanism that helps regulate the flow of aqueous humor from the eye to the external drainage tube. The AGV is implanted during a surgical procedure, and its design allows it to be placed in a variety of locations in the eye. The valve mechanism helps to regulate the flow of aqueous humor, and the device is designed to be long-lasting with a low risk of complications. The AGV is a well-established treatment option for patients with refractory glaucoma and has been used for many years in clinical practice.

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