Anterior Lens Capsule as a Spacer in the Deep Sclerectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-16

Study Completion Date

2024-06-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule

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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.

Non-penetrating deep sclerectomy and phacoemulsification

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

Group Type ACTIVE_COMPARATOR

Non-penetrating deep sclerectomy and phacoemulsification

Intervention Type PROCEDURE

This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.

Interventions

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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.

Intervention Type PROCEDURE

Non-penetrating deep sclerectomy and phacoemulsification

This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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