Outcome of GATT Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure.

Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure: A Prospective Case Series

To evaluate the intraocular pressure reduction effect of combined gonioscopy-assisted transluminal trabeculotomy (GATT) with goniosynechialysis in eyes with secondary synechial angle closure glaucoma.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Angle-Closure
• Intervention / Treatment: Other: Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis

Detailed Description

Glaucoma is a group of diseases that present with cupping of the optic nerve head and visual-field defects. It is the most common cause of irreversible blindness all over the world.Angle-closure glaucoma is a type of glaucoma characterized by narrowing or closure of the anterior chamber angle.

Two major types of angle closure glaucoma are defined by the mechanism of angle closure: in appositional contact, the iris is pushed by a pressure difference between the posterior and anterior chambers due to relative pupillary block, while in synechial contact, the peripheral iris adheres to the trabecular meshwork by peripheral anterior synechiae (PAS). PAS can develop in various ocular conditions, including: ocular inflammation, a post-traumatic condition, after cataract surgery, or with an iris bombe in a pupillary block glaucoma.

Grover et al. described a technique for ab-Interno circumferential trabeculotomy termed gonioscopy-assisted transluminal trabeculotomy (GATT). The procedure aims to create a 360° trabeculotomy from an ab-Interno approach.

GATT procedure is a MIGS technique in which trabecular meshwork is circumferentially bypassed by incising it using a suture or microcatheter.In this technique, aqueous humor passes through the collector channels and episcleral veins through the cleaved open diseased trabecular meshwork.

Elsayed et al previously demonstrated that combining phacoemulsification with GATT in PACG yielded more favorable outcomes in terms of IOP, glaucoma medications and surgical success compared to phacoemulsification alone.However, to date, no studies have looked at the outcomes of combining goniosynechialysis with GATT in secondary angle closure glaucoma. In fact, most studies looking at the outcomes of GATT in different types of glaucoma excluded eyes with synechial angle closure.

Goniosynechialysis (GSL) is the process of physically separating PAS, which can develop in the trabecular meshwork due to various conditions including primary and secondary cases of angle closure.

So, for those cases of synechial angle closure glaucoma combining GATT and GSL might aid in the IOP lowering effect required.

• Study Type: Interventional
• Enrollment (Estimated): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rokaya Radwan; Phone Number: +2 01066471468; Email: rokaia.e.radwan@students.kasralainy.edu.eg
• Study Contact Backup: Name: Fayrouz Aboalazaym; Phone Number: +2 01007419500; Email: fayrouzaboalazaym@gmail.com

Study Locations

• Egypt
  • Giza, Egypt, 11555
    • Recruiting
    • KasrAlainy Hospitals
    • Contact: Rokaya Radwan; Phone Number: +2 01066471468; Email: rokaia.e.radwan@students.kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with secondary synechial angle closure glaucoma
• Involving more than 180 degrees of the iridocorneal angle
• Requiring surgery for uncontrolled IOP despite maximum tolerated therapy.

Exclusion Criteria:

• Eyes with PACG.
• Eyes with neovascular glaucoma. (Some apparently stable NVG cases would have remnants of neo-vessels in the angle that are hidden behind the synechiae).
• Eyes with retinal pathology.
• Eyes requiring combined phacoemulsification and GATT.
• Eyes with corneal pathology that can preclude surgery and imaging.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Gatt combined with goinosynechiolysis in secondary synechial angle closure; Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure	Other: Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis; Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure; Other Names: GATT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP and glaucoma medications.	measurement of intra ocular pressure and documentation of number of anti glaucoma medications post operative	1day,1 week,1 months, 3 months, 6 months and 1 year
Surgical success.	Surgical success will be defined as: complete if IOP is less than or equal to 21mmHg without medications and qualified success if IOP is less than or equal to 21mmHg with medications. Failure will be the inability to achieve such a pressure, the need for another glaucoma operation or the development of a sight-threatening complication (e.g., retinal detachment, endophthalmitis)	1day,1 week,1 months, 3 months, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications.	rate of complications will be recorded	1day,1 week,1 months, 3 months, 6 months and 1 year

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: intra ocular pressure; secodary angle closure; GATT
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Angle-Closure
• Other Study ID Numbers: _MD-393-2023_

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: medical data including intraocular pressure and study outcomes will be shared but excluding any participant confidential data
• IPD Sharing Time Frame: After publication within 18 months
• IPD Sharing Access Criteria: will be uploaded
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No