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The Ghana Primary Tube Versus Trabeculectomy Study

NCT02088528 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2014-03-17

No results posted yet for this study

Summary

Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of medications, disease severity and poor compliance. Surgical treatment is likely to be a more practical solution.

The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical study.

Conditions

Interventions

DEVICE

Aurolab glaucoma drainage device

Patients undergoing surgery will receive an implant

PROCEDURE

Trabeculectomy with mitomycin-c

Trabeculectomy surgery augmented by application of mitomycin C (0.4 mg/ml) to the sclera in the region of the trabeculectomy site for a period of exactly 3 minutes.

Sponsors & Collaborators

  • International Glaucoma Association

    collaborator UNKNOWN

  • HCA International Foundation

    collaborator UNKNOWN

  • Tema Christian Eye Center

    lead OTHER

Principal Investigators

  • Alexander Spratt, MBBCh FRCOphth · Tema Christian Eye Center

  • Keith Barton, MBBCh MD FRCP FRCOphth · Moorfields Eye Hospital NHS Foundation Trust

  • Donald L Budenz, MD MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2021-03-31

Countries

  • Ghana

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02088528 on ClinicalTrials.gov