Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

Glaucoma Clinical Trial

Official title:

Topical vs Injection Application of Mitomycin C Trabeculectomy Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02744690
• Other study ID #: 15-16075-MMC
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: March 1, 2019

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application.

Description:

This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, patients from Menelik Hospital who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive mitomycin C applied topically or by injection during the surgery.At Menelik Hospital mitomycin-C (MMC) is routinely applied to the eye prior to trabeculectomy by physicians via both sponge and injection routes. The primary outcome is the patient's response to the trabeculectomy procedure, as measured by cumulative complications after a 3-month follow-up period post-operation. Secondary outcome is the change in intraocular pressure after a 3 month follow-up period. The investigators will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Mitomycin-C (MMC)
Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital

Locations

Country	Name	City	State
Ethiopia	Menelik II Hospital	Addis Ababa

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Menelik II Hospital

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of complications	Comparison of the cumulative incidence of complications between the treatment groups (MMC sponge and injection application) 3 months after surgery	3 months after surgery
Secondary	Cumulative incidence of complications	Comparison of the cumulative incidence of complications between the treatment groups (sponge and injection application of MMC) 6 months and 12 months after surgery	6 and 12 months after surgery
Secondary	Reduction of intraocular pressure from baseline, mmHg	The investigators will compare the reduction of IOP from baseline between the treatment groups at 3, 6, and 12 months after surgery	3, 6, and 12 months after surgery