AGV Implantation With Ologen in Pediatric Glaucomas

Summary

Ahmed Glaucoma Valve Implantation with Ologen augmentation in secondary pediatric glaucomas: A 2-year randomized controlled trial.

Background:

Many studies have investigated the clinical benefits of Ologen for trabeculectomy. However, its benefits for Ahmed glaucoma valve implantation have not been widely investigated.

Purpose:

The aim of this study was to compare the 2-year outcomes of AGV implantation with and without Ologen adjuvant for the treatment of children with 2ry pediatric glaucoma. Design: This is a single-center, randomized, controlled study. Participants: Consecutive children with refractory pediatric glaucoma requiring AGV implantation were enrolled in this study.

Methods:

Refractory pediatric glaucoma was defined by at least 2 repeated IOP measurements greater than 21 mmHg and accompanying signs of buphthalmos, corneal edema, Haabs striae, or optic nerve cupping despite maximal tolerated medical therapy. The primary outcome measure was AGV success. Complete success was defined as intraocular pressure (IOP) between 6 and 20 mmHg without glaucoma medications and additional IOP-lowering surgeries. Qualified success was defined as above, except IOP control maintained with glaucoma medications. In Ologen eyes, a round 12 × 1 mm circular Ologen disc will be placed over the FP7 or FP8 AGV-plate immediately before conjunctival closure. Control eyes received conventional FP7 or FP8 AGV surgery without Ologen augmentation.

Conditions

• Glaucoma

Interventions

PROCEDURE

Ahmed Glaucoma Valve Implantation in secondary pediatric glaucomas.

A 7-0 silk traction suture was placed through the clear cornea.A conjunctival incision was made 4 mm posterior to the limbus in the supratemporal quadrant. After dissecting conjunctiva and Tenon's primed FP7 or FP8 AGV was inserted into the subconjunctival space and sutured to sclera using two interrupted 7-0 silk sutures 8-10 mm posterior to the limbus. A 23-gauge needle was used to enter the anterior chamber from the surgical limbus. The tube then was cut beveled up and inserted into the anterior chamber through the tunnel. Finally, conjunctiva and Tenon were approximated using a running 8-0 Vicryl suture.At the close of surgery, subtenon antibiotic and steroids were injected in all cases.

PROCEDURE

Ahmed Glaucoma Valve Implantation with Ologen augmentation in secondary pediatric glaucomas

A 7-0 silk traction suture was placed through the clear cornea.A conjunctival incision was made 4 mm posterior to the limbus in the supratemporal quadrant. After dissecting conjunctiva and Tenon's primed FP7 or FP8 AGV was inserted into the subconjunctival space and sutured to sclera using two interrupted 7-0 silk sutures 8-10 mm posterior to the limbus. A 23-gauge needle was used to enter the anterior chamber from the surgical limbus. The tube then was cut beveled up and inserted into the anterior chamber through the tunnel. a round 12 × 1 mm circular Ologen disc will be placed over the FP7 or FP8 AGV-plate immediately before conjunctival closure. Finally, conjunctiva and Tenon were approximated using a running 8-0 Vicryl suture.At the close of surgery, subtenon antibiotic and steroids were injected in all cases.

Sponsors & Collaborators

• Mansoura University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-31

Primary Completion

2023-12-31

Completion

2024-01-31