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

NCT06739343 | Completed DMC

• 1 other identifier: ECWA/HREC/004/2022
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Glaucoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP)

  The primary outcome measure is the change in intraocular pressure (IOP) from baseline to 12 months postoperatively. IOP will be measured using the Goldmann Applanation Tonometer, the gold standard for IOP measurement. Measurements will be recorded in millimeters of mercury (mmHg). The change in intraocular pressure (IOP) will reflect the effectiveness of the surgical intervention in controlling IOP over time. Lower IOP values within the normal range (10-21 mmHg) indicate successful pressure regulation and better surgical outcomes, reducing the risk of glaucoma progression. Conversely, persistently elevated IOP values may suggest surgical failure The changes in IOP will be compared between the Phaco-Trabeculectomy and MSICS-Trabeculectomy groups to assess the efficacy of each surgical technique in controlling intraocular pressure over the study duration.

  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 (3)

• Best-Corrected Visual Acuity (BCVA)

  Baseline, Month 1, Month 3, Month 6, and Month 12 post-surgery

• Postoperative Complications

  Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery.

• Bleb Function

  Month 1, Month 3, Month 6, and Month 12 post-surgery

Other Outcomes (4)

• Patient-Reported Satisfaction

  Month 3 and Month 12 post-surgery

• Patient-Reported Quality of Life

  Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery.

• Duration of Surgery

  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.

Study Arms (2)

PHACO-Trabeculectomy Group

ACTIVE COMPARATOR

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.

Procedure: PHACO-Trabeculectomy; Procedure: MSICS-Trabeculectomy

MSICS-Trabeculectomy Group

ACTIVE COMPARATOR

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.

Procedure: PHACO-Trabeculectomy; Procedure: MSICS-Trabeculectomy

Interventions

PHACO-Trabeculectomy 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 Group; PHACO-Trabeculectomy Group

MSICS-Trabeculectomy 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; PHACO-Trabeculectomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emeka John Dingwoke: lead
• Ahmadu Bello University Teaching Hospital: collaborator

Study Sites (1)

ECWA Eye hospital

Kano, Kano State, Nigeria

Location

Related Publications (1)

• Munaje MI, Aribaba OT, Atima MO, Idakwo U, Pam JD, Dingwoke EJ, Gandi NB. Phaco-trabeculectomy versus MSICS-trabeculectomy for coexisting cataract and glaucoma: visual and IOP outcomes from a randomized trial in Nigeria. BMC Ophthalmol. 2025 Nov 5;25(1):621. doi: 10.1186/s12886-025-04482-1.

  PMID: 41194003 DERIVED

MeSH Terms

Conditions

Cataract; Glaucoma

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Ocular Hypertension

Study Officials

• Mayor Orezime Atima, FWACS

  ECWA Eye Hospital, Kano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 18, 2024
• Study Start: September 21, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start Date: 6 months after the publication of study results End Date: Available for 5 years following publication.
• Access Criteria: Who Will Have Access: Qualified researchers affiliated with academic institutions, research organizations, or healthcare entities will be eligible to request access. What Will Be Accessible: De-identified individual participant data (IPD) relevant to primary and secondary outcome measures, along with supporting documentation such as the study protocol, statistical analysis plan, and informed consent templates. How Access Will Be Granted: Interested researchers must submit a formal request including a detailed research proposal outlining the intended use of the data. Requests will be reviewed by a data-sharing committee or principal investigator. Approved researchers will be required to sign a data-sharing agreement ensuring data confidentiality, compliance with ethical guidelines, and appropriate use of the data. Access Mechanism: Data will be shared via a secure online repository or data-sharing platform. Approved researchers will receive time-limited credentials to access the data

Locations

NG (1)