Comparison of Phaco-Trabeculectomy and MSICS-Trab in Cataract and Glaucoma Patients

Summary

The goal of this interventional study is to compare the outcomes of two surgical techniques, Phaco-Trabeculectomy and Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy, in patients with coexisting cataract and glaucoma at ECWA Eye Hospital, Kano, Nigeria. The study aims to evaluate which technique offers better intraocular pressure (IOP) control, visual acuity improvement, and complication rates postoperatively.

The main questions the study seeks to answer are:

Does Phaco-Trabeculectomy provide superior IOP control compared to MSICS-Trabeculectomy in patients with coexisting cataract and glaucoma? Which technique is associated with fewer postoperative complications? How do the visual outcomes compare between the two techniques? Participants will be randomly assigned to undergo one of the two surgical techniques based on a predefined protocol. Data will be collected on intraoperative and postoperative parameters, including IOP, visual acuity, and the incidence of complications, with follow-ups extending over a 12-month period.

This study aims to provide evidence to guide clinicians in selecting the most effective and safe surgical approach for managing patients with cataract and glaucoma in resource-limited settings.

Conditions

• Cataract
• Glaucoma

Interventions

PROCEDURE

PHACO-Trabeculectomy

Phaco-Trabeculectomy is a combined surgical procedure that integrates phacoemulsification, a modern cataract extraction technique using ultrasound, with trabeculectomy, a glaucoma filtration surgery. This intervention is distinguished by its precision, minimal incision size, and suitability for patients with coexisting cataract and glaucoma. Phacoemulsification efficiently emulsifies and aspirates the cataract through a small incision, while trabeculectomy creates a filtration bleb to lower intraocular pressure (IOP). This combination allows for simultaneous management of both conditions, particularly in cases where phacoemulsification is preferred for cataract extraction.

PROCEDURE

MSICS-Trabeculectomy

Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy is a cost-effective, combined surgical approach involving a manual technique for cataract removal alongside glaucoma filtration surgery. MSICS utilizes a larger incision than phacoemulsification, allowing for the manual extraction of the cataract nucleus. This procedure is particularly advantageous in resource-limited settings where phacoemulsification equipment may not be available. The trabeculectomy component is the same as in the PHACO-Trabeculectomy intervention, providing effective IOP reduction through the creation of a filtration bleb.

Sponsors & Collaborators

• Ahmadu Bello University Teaching Hospital

  collaborator OTHER

• Emeka John Dingwoke

  lead OTHER

Principal Investigators

• Mayor Orezime Atima, FWACS · ECWA Eye Hospital, Kano

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-21

Primary Completion

2024-09-30

Completion

2024-09-30

Countries

• Nigeria

Study Locations