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NCT06739343

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

Completed NA Last updated 18 December 2024
What this trial tests

NA trial testing PHACO-Trabeculectomy in Cataract in 122 participants. Completed in 30 September 2024.

Timeline
21 September 2022
Primary endpoint
30 September 2024
30 September 2024

Quick facts

Lead sponsorEmeka John Dingwoke
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment122
Start date21 September 2022
Primary completion30 September 2024
Estimated completion30 September 2024
Sites1 location across Nigeria

Drugs / interventions tested

Conditions studied

Sponsor

Emeka John Dingwoke

Who can join

18 and older, any sex, with Cataract or Glaucoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Phaco-trabeculectomy versus MSICS-trabeculectomy for coexisting cataract and glaucoma: visual and IOP outcomes from a randomized trial in Nigeria.
    Munaje MI, Aribaba OT, Atima MO, Idakwo U, et al · · 2025 · PMID 41194003 · DOI 10.1186/s12886-025-04482-1

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