Supracapsular Ahmed Glaucoma Valve Plate Delivery Technique for Management of Encapsulated Bleb in Pediatric Patients

NCT04931290 | Completed

• 1 other identifier: R.21.03.1246.R1.R2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the safety and efficacy of supracapsular Ahmed Glaucoma Valve plate delivery for management of encapsulated bleb in pediatric patients with failed Ahmed Glaucoma Valve. This is a prospective interventional study. It will be conducted in Mansoura University in the duration from April 2020 to January 2021. The study will include pediatric patients less than 18 years with failed AGV with encapsulated bleb and high IOP above 21 mm Hg in two consecutive visits inspite of topical glaucoma medications

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• Intraocular pressure

  IOP

  6 month

• success rates

  IOP ≤ 21 mmHg without medications indicates complete success while IOP ≤ 21 mmHg with medications indicates qualified success, an IOP \<6 mmHg i defined as hypotony and IOP above 21 mm Hg with medications indicates failure

  6 month

Study Arms (1)

supracapsular delivery of plate of valve

EXPERIMENTAL

ncision of the perilimbal superior temporal conjunctiva with separation of the conjunctiva from the Tenon's capsule till reaching the encapsulated valve plate. Incision of the capsule in a z pattern will be done then the plate is dissected from the tissues and delivered out of the capsule through the opening to the subconjunctival space.The mobility of AGV and its tube will be evaluated and refixation of the plate will be done if needed. The plate will be covered with ologen implant sizing 12mm width and 1 mm thickness. The conjunctiva will be closed by 10/0 nylon sutures.

Procedure: Supracapsular Ahmed Glaucoma Valve plate delivery technique

Interventions

Supracapsular Ahmed Glaucoma Valve plate delivery technique PROCEDURE

incision of the perilimbal superior temporal conjunctiva with separation of the conjunctiva from the Tenon's capsule till reaching the encapsulated valve plate. Incision of the capsule in a z pattern will be done then the plate is dissected from the tissues and delivered out of the capsule through the opening to the subconjunctival space.The mobility of AGV and its tube will be evaluated and refixation of the plate will be done if needed. The plate will be covered with ologen implant sizing 12mm width and 1 mm thickness. The conjunctiva will be closed by 10/0 nylon sutures.

supracapsular delivery of plate of valve

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• pediatric patients less than 18 years with failed AGV with encapsulated bleb and high IOP above 21 mm Hg in two consecutive visits inspite of topical glaucoma medications

You may not qualify if:

• intraocular inflammations or ocular surface diseases

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Dina Abd Elfattah

Al Mansurah, Dakahlia Governorate, 35100, Egypt

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Dina AbdElfattah, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of ophthalmology

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 18, 2021
• Study Start: April 6, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

EG (1)