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

Glaucoma, Angle-Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445634
• Other study ID #: _MD-393-2023_
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: Kasr El Aini Hospital
• Contact: Rokaya Radwan
• Phone: 01066471468
• Email: rokaia.e.radwan[@]students.kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Other:
• Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis
Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure

Locations

Country	Name	City	State
Egypt	Kasralainy Hospitals	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Complications.	rate of complications will be recorded	1day,1 week,1 months, 3 months, 6 months and 1 year