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

Shahid Beheshti University of Medical Sciences

Status: Active, not recruiting

Conditions: Cataract; Glaucoma

Treatments: Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule; Procedure: Non-penetrating deep sclerectomy and phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT05906212

14021

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Patients with concomitant uncontrolled glaucoma and significant cataract
• Progression in glaucoma despite medical treatment
• Age more than 18 years old

Exclusion criteria

• Prior ocular surgery
• Neovascular glaucoma or uveitic glaucoma
• Compromised ocular surface or insufficient conjunctiva

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule

Experimental group

Description:

The intervention group will be undergoing non-penetrating deep sclerectomy and phacoemulsification with the use of an autotransplantation of the human anterior lens capsule as the spacer in the intrascleral lake.

Treatment:

Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule

Non-penetrating deep sclerectomy and phacoemulsification

Active Comparator group

Description:

The control group will be undergoing non-penetrating deep sclerectomy and phacoemulsification without any spacer.

Treatment:

Procedure: Non-penetrating deep sclerectomy and phacoemulsification