NCT05906212

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma
• Cataract

Interventions

Type	Name	Description
PROCEDURE	Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule	This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.
PROCEDURE	Non-penetrating deep sclerectomy and phacoemulsification	This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.

Timeline

• Start date: 2023-05-16
• Primary completion: 2024-05-16
• Completion: 2024-06-16
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: Iran