AGV Implantation With Ologen in Pediatric Glaucomas

NCT05014386 | Unknown DMC

• 1 other identifier: AGV with ologen in SPG
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Ahmed Glaucoma Valve; Ologen; secondary pediatric glaucomas

Outcome Measures

Primary Outcomes (1)

• 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 that IOP control was maintained with glaucoma medications.

  2 years

Secondary Outcomes (2)

• cup to disc ratios

  2 years

• postoperative complications

  2 years

Study Arms (2)

Ahmed Glaucoma Valve Implantation

ACTIVE COMPARATOR

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 in secondary pediatric glaucomas.

Ologen augmentation group

ACTIVE COMPARATOR

In addition to what is planned for the other Arm;, a round 12 × 1 mm circular Ologen disc will be placed over the FP7 or FP8 AGV-plate immediately before conjunctival closure.

Procedure: Ahmed Glaucoma Valve Implantation with Ologen augmentation in secondary pediatric glaucomas

Interventions

Ahmed Glaucoma Valve Implantation in secondary pediatric glaucomas. PROCEDURE

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.

Ahmed Glaucoma Valve Implantation

Ahmed Glaucoma Valve Implantation with Ologen augmentation in secondary pediatric glaucomas PROCEDURE

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.

Ologen augmentation group

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Primary congenital glaucoma

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Amr Mohammed Elsayed A Mohammed, MD, FRCS

CONTACT

01004314242; dramrabdelkader@gmail.com

Ahmed Elwehidy, MD

CONTACT

01009922107; aselwehidy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of ophthalmology

Model Details: This is a single-center, randomized, controlled couple armed study.

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 years
• Access Criteria: IPD will be provided with publications as supplementary digital content