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Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

Primary Purpose

Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Glaucoma Drainage Device
Sponsored by
Al Watany Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maadi eye subspeciality centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Paul Glaucoma Implant

Ahmed Glaucoma valve

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

IOP Reduction
More than 20% change from baseline without development of vision threatening complications

Secondary Outcome Measures

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?)
Post-operative complications

Full Information

First Posted
March 12, 2023
Last Updated
April 2, 2023
Sponsor
Al Watany Eye Hospital
Collaborators
Moorfields Eye Hospital Centre Abu Dhabi
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1. Study Identification

Unique Protocol Identification Number
NCT05797350
Brief Title
Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma
Official Title
Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al Watany Eye Hospital
Collaborators
Moorfields Eye Hospital Centre Abu Dhabi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paul Glaucoma Implant
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ahmed Glaucoma valve
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Glaucoma Drainage Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
IOP Reduction
Description
More than 20% change from baseline without development of vision threatening complications
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Glaucoma Medication Alterations
Description
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?)
Time Frame
1 year
Title
Post-operative complications
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed ElBaharwy
Phone
+201144777100
Email
momaryo@hotmail.com
Facility Information:
Facility Name
Maadi eye subspeciality center
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed om yousif, MD,FRCS
Phone
01001682091
Email
momaryo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Eman sa muhammed, MD,FRCS
Phone
01007421427
Email
nana_samir_11@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

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