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NCT06739343Completed

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

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

Source: ClinicalTrials.gov · Last updated 18 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
122 (actual)
First submitted
11 Dec 2024
Start date
21 Sept 2022
Primary completion date
30 Sept 2024
Lead sponsor
Emeka John Dingwoke
Diseases
Glaucoma
NCT number
NCT06739343

What you commit to

  • Study type: Interventional
  • Participants enrolled: 122
  • From 21 Sept 2022 to the primary completion date, 30 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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).

Other

  • Patients with angle-closure glaucoma.
  • Patients with secondary glaucoma or glaucoma-associated ocular or systemic anomalies.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ECWA Eye hospital
Coordinator of this site? Confirm its status		KanoNigeriaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.