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

NCT ID: NCT06739343

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2024-09-30

Brief 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.

Detailed Description

Background and Rationale Cataract and glaucoma are two of the leading causes of preventable blindness globally, presenting significant public health challenges, particularly in resource-limited settings such as Nigeria. The coexistence of cataract and glaucoma complicates surgical management, as cataract surgery alone may improve visual acuity but is insufficient to achieve long-term control of intraocular pressure (IOP) in glaucoma patients.

Combined surgical procedures, such as Phaco-Trabeculectomy and Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy, have been adopted to address these dual ocular conditions in a single intervention. However, evidence comparing the efficacy, safety, and long-term outcomes of these two approaches remains limited, particularly in Sub-Saharan Africa. This study seeks to bridge this critical gap in clinical evidence by generating region-specific data to optimize surgical decision-making for patients with coexisting cataract and glaucoma.

ECWA Eye Hospital, Kano, a tertiary eye care center in Nigeria renowned for its excellence in ophthalmology, provides the ideal setting for conducting this interventional study.

Study Objectives

This study aims to:

Determine whether Phaco-Trabeculectomy or MSICS-Trabeculectomy offers superior intraocular pressure (IOP) control in patients with coexisting cataract and glaucoma.

Compare the visual acuity outcomes between the two surgical techniques. Evaluate and compare the incidence of postoperative complications, such as bleb failure, hypotony, and infection.

Assess patient satisfaction and quality of life using validated questionnaires.

Study Design

This is a randomized, parallel-group, interventional study conducted over a 12-month follow-up period. Eligible participants are randomized into two arms using a block randomization approach to ensure balanced allocation:

Phaco-Trabeculectomy Group MSICS-Trabeculectomy Group Randomization minimizes selection bias and ensures comparability of baseline characteristics between groups.

Key Surgical Interventions Phaco-Trabeculectomy This procedure integrates phacoemulsification, a modern cataract extraction technique, with trabeculectomy to achieve IOP control.

A 3.2 mm corneal incision is made for ultrasonic emulsification and aspiration of the cataract.

A trabeculectomy is performed to create a filtration bleb, facilitating aqueous humor drainage.

This method is precise, minimally invasive, and well-suited for modern ophthalmic practice.

MSICS-Trabeculectomy This procedure combines manual extracapsular cataract extraction with trabeculectomy and is particularly advantageous in resource-limited settings.

A fornix-based conjunctival flap is raised, and a larger manual incision is made to remove the cataract nucleus.

Trabeculectomy is performed using the same technique as in the Phaco-Trabeculectomy group.

The MSICS-Trabeculectomy approach is practical, cost-effective, and suitable for environments where phacoemulsification equipment is unavailable.

Postoperative Management

Standardized postoperative care includes:

Administration of topical corticosteroids, antibiotics, and anti-glaucoma medications to reduce inflammation, prevent infection, and manage IOP.

Follow-up visits conducted on day 1, week 1, months 1, 3, 6, and 12 to assess clinical outcomes and monitor for complications, including hypotony, bleb failure, and infection.

Bleb morphology is evaluated using validated grading systems, while patient satisfaction and quality of life are assessed using standardized questionnaires.

Data Collection and Analysis

Data on surgical outcomes, including IOP, visual acuity, and postoperative complications, are systematically collected at predefined intervals. Statistical tools are employed for comparative analysis:

Continuous variables such as IOP and visual acuity are analyzed using paired and unpaired t-tests.

Categorical variables, including complication rates, are analyzed using chi-square tests and logistic regression models.

Results will be presented as mean ± standard deviation for continuous variables and as percentages for categorical variables.

Significance of the Study

This study provides a direct comparative analysis of Phaco-Trabeculectomy and MSICS-Trabeculectomy in a Sub-Saharan African context. By evaluating clinical efficacy, cost-effectiveness, and patient-reported outcomes, the findings will:

Inform clinical practice by identifying the optimal surgical approach for managing coexisting cataract and glaucoma.

Address regional gaps in evidence-based ophthalmic care, particularly in resource-limited settings.

Serve as a foundation for further studies exploring long-term surgical outcomes and innovations in glaucoma-cataract management.

Novel Contributions

This study is one of the first to comprehensively evaluate two combined surgical techniques in a Sub-Saharan African population. Its strengths include:

Rigorous randomization to ensure unbiased comparisons. Systematic data collection at predefined intervals over 12 months. Use of validated tools for assessing bleb morphology, complications, and patient satisfaction.

By bridging the gap in clinical evidence, this study has the potential to improve surgical decision-making, enhance patient outcomes, and guide ophthalmic care strategies in resource-constrained settings.

Conclusion This interventional study will provide critical insights into the comparative effectiveness and safety of Phaco-Trabeculectomy and MSICS-Trabeculectomy for managing coexisting cataract and glaucoma. Its findings are expected to have significant implications for ophthalmic practice in Nigeria and other resource-limited regions, ultimately contributing to the prevention of avoidable blindness.

Conditions

Cataract; Glaucoma

Keywords

Cataract; Glaucoma; Phaco-Trabeculectomy; MSICS-Trabeculectomy; Intraocular Pressure; Visual Acuity; ECWA Eye Hospital; Surgical Outcomes; Combined Surgery; Ophthalmology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PHACO-Trabeculectomy Group

Participants in this group underwent Phaco-Trabeculectomy, a combined surgical procedure that involves phacoemulsification (modern cataract extraction technique) and trabeculectomy (a glaucoma filtration surgery). This procedure is designed to address both cataract removal and intraocular pressure (IOP) reduction in a single surgery.

Interventions:

Phacoemulsification: Ultrasound-based cataract removal. Trabeculectomy: Creation of a filtration bleb to lower IOP.

Group Type: ACTIVE_COMPARATOR

PHACO-Trabeculectomy

Intervention Type: PROCEDURE

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.

MSICS-Trabeculectomy

Intervention Type: PROCEDURE

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.

MSICS-Trabeculectomy Group

Participants in this group underwent Manual Small Incision Cataract Surgery (MSICS) combined with trabeculectomy. This procedure, which uses a manual technique for cataract extraction, is often more cost-effective and suitable for resource-limited settings while also addressing IOP reduction.

Interventions:

Manual Small Incision Cataract Surgery (MSICS): A manual extracapsular cataract extraction technique.

Trabeculectomy: Same filtration procedure as in the Phaco-Trabeculectomy group to manage glaucoma.

Group Type: ACTIVE_COMPARATOR

PHACO-Trabeculectomy

Intervention Type: PROCEDURE

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.

MSICS-Trabeculectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients aged ≥18 years.
• Patients diagnosed with coexisting cataracts and primary open-angle glaucoma.
• Patients who have provided informed consent to participate in the study.

Exclusion Criteria

• Patients with angle-closure glaucoma.
• Patients with secondary glaucoma or glaucoma-associated ocular or systemic anomalies.
• Patients with a history of ocular surgeries, such as trabeculectomy, cataract surgery, or other glaucoma surgeries.
• Patients with corneal or anterior segment diseases that could impede detailed examination (e.g., scleritis, bullous keratopathy, corneal scarring, corneal degenerations, or uveitis).
• Patients with posterior segment diseases affecting visual interpretation (e.g., diabetic retinopathy, hypertensive retinopathy, high axial myopia, retinal detachment, vitreous hemorrhage, macular degeneration, central retinal vein occlusion, or sickle cell retinopathy).
• Patients unwilling to provide voluntary informed consent or those who chose to withdraw from the study at any point.
• Patients with only one functional eye.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmadu Bello University Teaching Hospital

OTHER

Sponsor Role: collaborator

Emeka John Dingwoke

OTHER

Sponsor Role: lead

Responsible Party

Emeka John Dingwoke

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mayor Orezime Atima, FWACS

Role: STUDY_CHAIR

ECWA Eye Hospital, Kano

Locations

ECWA Eye hospital

Kano, Kano State, Nigeria

Countries

Nigeria

Other Identifiers

ECWA/HREC/004/2022

Identifier Type: -

Identifier Source: org_study_id