Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

• Register: ClinicalTrials.gov
• Last refreshed on: 7 August 2023
• Main ID: NCT02744690
• Date of registration: 11/02/2016
• Prospective Registration: No
• Primary sponsor: University of California, San Francisco
• Public title: Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia
• Scientific title: Topical vs Injection Application of Mitomycin C Trabeculectomy Trial
• Date of first enrolment: March 1, 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/ct2/show/NCT02744690
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Ethiopia

Contacts

• Name: Jeremy D Keenan, MD, MPH
• Affiliation: University of California, San Francisco

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age >=40

- Planning to have a trabeculectomy

Exclusion Criteria:

- Life threatening or debilitating disease

- Inability to complete necessary exams and/or ocular disease that would preclude
assessment of intraocular pressure, visual field, or optic disc

- Pseudophakic lens

- Contralateral eye already enrolled in study



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Glaucoma

Intervention(s)

Drug: Mitomycin-C (MMC)

Primary Outcome(s)

Cumulative incidence of complications [Time Frame: 3 months after surgery]

Secondary Outcome(s)

Cumulative incidence of complications [Time Frame: 6 and 12 months after surgery]

Reduction of intraocular pressure from baseline, mmHg [Time Frame: 3, 6, and 12 months after surgery]

Secondary ID(s)

15-16075-MMC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Menelik II Hospital