Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

Glaucoma Clinical Trial

Official title:

Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797350
• Other study ID #: AlWatanyEyeH
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2023
• Source: Al Watany Eye Hospital
• Contact: Mohamed ElBaharwy
• Phone: +201144777100
• Email: momaryo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

Locations

Country	Name	City	State
Egypt	Maadi eye subspeciality center	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Al Watany Eye Hospital	Moorfields Eye Hospital Centre Abu Dhabi

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP Reduction	More than 20% change from baseline without development of vision threatening complications	1 year
Secondary	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
Secondary	Post-operative complications		1 year