An interventional study of Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma, Angle-Closure, sponsored by Kasr El Aini Hospital. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Treatment
To evaluate the intraocular pressure reduction effect of combined gonioscopy-assisted transluminal trabeculotomy (GATT) with goniosynechialysis in eyes with secondary synechial angle closure glaucoma.
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.
91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.
This study's planned enrollment of 23 is below the median of 57 across 58 interventional studies indexed under Glaucoma, Angle-Closure.
Browse Glaucoma, Angle-Closure studies →Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
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
Also known as: GATT
IOP and glaucoma medications.
measurement of intra ocular pressure and documentation of number of anti glaucoma medications post operative
Time frame: 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)
Time frame: 1day,1 week,1 months, 3 months, 6 months and 1 year
Complications.
rate of complications will be recorded
Time frame: 1day,1 week,1 months, 3 months, 6 months and 1 year
Plan to share: Yes — medical data including intraocular pressure and study outcomes will be shared but excluding any participant confidential data
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After publication within 18 months
Access criteria: will be uploaded
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Aug 2025, 16 months after the start.
Of 28 interventional studies with no phase under Glaucoma, Angle-Closure, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 43. This study's planned 16 months is below that.
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