Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification

Cataract Clinical Trial

Official title: Use of Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification: A Randomized Clinical Trial

Status Active, not recruiting

Clinical Trial Summary

In this randomized clinical trial, patients with concomitant glaucoma and cataract candidate for non-penetrating deep sclerectomy (NPDS) and phacoemulsification (PE) and subtenon mitomycin injection will be enrolled. Patients will randomly be allocated to two groups ["NPDS and PE and autotransplantation of human anterior lens capsule (ALC)" and "NPDS and PE" alone]. Exclusion criteria will be the patients with prior ocular surgery, neovascular glaucoma, uveitis, or compromised ocular surface. The intervention group will be undergoing NPDS and PE with the use of an ALC as the spacer in the intrascleral lake. The control group will be undergoing NPDS and PE without any spacer. The primary outcome will be intraocular pressure measured on days 1, 3, 7, months 1, 3, 6, and 12. The secondary outcomes will be surgical success rate (complete and qualified), the number of glaucoma medications, best-corrected visual acuity, surgical complications, and the need for needling and laser goniopuncture measured at the same intervals. The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication. The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cataract
• Glaucoma

• NCT number: NCT05906212
• Study type: Interventional
• Source: Shahid Beheshti University of Medical Sciences
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 16, 2023
• Completion date: June 16, 2024