Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

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

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Device: Glaucoma Drainage Device

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed ElBaharwy; Phone Number: +201144777100; Email: momaryo@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Maadi eye subspeciality center
    • Contact: Mohamed om yousif, MD,FRCS; Phone Number: 01001682091; Email: momaryo@hotmail.com
    • Contact: Eman sa muhammed, MD,FRCS; Phone Number: 01007421427; Email: nana_samir_11@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paul Glaucoma Implant; 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.	Device: Glaucoma Drainage Device; Both the Paul glaucoma implant (PGI) and Ahmed glaucoma valve (AGV) are types of glaucoma drainage devices (GDDs) used to lower intraocular pressure in patients with refractory glaucoma. Devices will be implanted during a surgical procedure and work by diverting excess fluid from the eye to an external drainage tube, allowing the fluid to drain away from the eye and be absorbed into the surrounding tissue. This will help to lower the pressure inside the eye, which is important for preventing vision loss and other complications associated with glaucoma.
Active Comparator: Ahmed Glaucoma valve; 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.	Device: Glaucoma Drainage Device; Both the Paul glaucoma implant (PGI) and Ahmed glaucoma valve (AGV) are types of glaucoma drainage devices (GDDs) used to lower intraocular pressure in patients with refractory glaucoma. Devices will be implanted during a surgical procedure and work by diverting excess fluid from the eye to an external drainage tube, allowing the fluid to drain away from the eye and be absorbed into the surrounding tissue. This will help to lower the pressure inside the eye, which is important for preventing vision loss and other complications associated with glaucoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP Reduction	More than 20% change from baseline without development of vision threatening complications	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glaucoma Medication Alterations	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?)	1 year
Post-operative complications		1 year

Collaborators and Investigators

• Sponsor: Al Watany Eye Hospital
• Collaborators: Moorfields Eye Hospital Centre Abu Dhabi

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 12, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: AlWatanyEyeH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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