Clinical trial NCT06739343: Comparison of Phaco-Trabeculectomy and MSICS-Trab in Cataract and Glaucoma Patients
Official title: Comparison of Phaco-Trabeculectomy Versus Combined Manual Small Incision Cataract Surgery with Trabeculectomy in Patients with Coexisting Cataract and Glaucoma At ECWA Eye Hospital, Kano, Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Glaucoma
Keywords: Cataract
Glaucoma
Phaco-Trabeculectomy
MSICS-Trabeculectomy
Intraocular Pressure
Visual Acuity
ECWA Eye Hospital
Surgical Outcomes
Combined Surgery
Ophthalmology
Lead sponsor: UNESCO International Centre for Biotechnology, Nigeria
Sponsor class: OTHER
Collaborators: name: Ahmadu Bello University Teaching Hospital
First posted: 2024-12-18
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study follows a parallel group design, where eligible participants are randomly assigned to one of two independent intervention arms: the Phaco-Trabeculectomy group or the MSICS-Trabeculectomy group. Each group receives a distinct surgical intervention, and participants remain in their assigned groups throughout the study duration. Outcomes are measured and compared between the two groups to evaluate the relative effectiveness and safety of the interventions.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Intraocular Pressure (IOP)
timeFrame: Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery. To determine the relative effectiveness of the two surgical techniques in managing glaucoma-related elevated IOP.
Secondary outcomes:
measure: Best-Corrected Visual Acuity (BCVA)
timeFrame: Baseline, Month 1, Month 3, Month 6, and Month 12 post-surgery
measure: Postoperative Complications
timeFrame: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery.
measure: Bleb Function
timeFrame: Month 1, Month 3, Month 6, and Month 12 post-surgery
Other outcomes:
measure: Patient-Reported Satisfaction
timeFrame: Month 3 and Month 12 post-surgery
measure: Patient-Reported Quality of Life
timeFrame: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery.
measure: Duration of Surgery
timeFrame: Intraoperative (30-90 minutes). The intraoperative period spans the duration of the surgical intervention, beginning with anesthesia administration and ending upon completion of the procedure.
measure: Cost Analysis
timeFrame: Throughout the study duration (baseline, 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months). Data will be collected at these specific time points to evaluate outcomes across the study period.
Locations:
city: Kano
country: Nigeria
facility: ECWA Eye hospital
state: Kano State
Study officials:
affiliation: ECWA Eye Hospital, Kano
name: Mayor Orezime Atima, FWACS
role: STUDY_CHAIR
References: