MedTrace Logo

Surgical Approaches in Treating Uncontrolled Glaucoma in Black African and African-Caribbeans

NCT02989207 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-12-12

No results posted yet for this study

Summary

The aim is to perform a randomised feasibility trial preceding a large prospective randomised controlled trial (RCT) comparing three surgical methods - trabeculectomy with Mitomycin C (MMC), primary Baerveldt tube with MMC and Baerveldt tube without MMC - in black African/African Caribbean patients with Primary Open Angle Glaucoma (POAG) living in London.

The UK Office of National Statistics estimated that among the population of England in 2007, approximately 4.3% were of African/African-Caribbean background, while in large cities such as London and Birmingham about 20% of the population is of African/African-Caribbean origin. For eye units in these cities, managing glaucoma in this population is challenging and we need to identify a better alternative to our current standard surgical treatment.

There is now evidence from one RCT which shows better overall outcomes from tube surgery in comparison to trabeculectomy for glaucoma. However, this study did not address black populations specifically and did not address the potential role of MMC in tube surgery.

This feasibility study will enable us to design a fully powered RCT with the aim of determining how best to optimise the surgical treatment of POAG in black populations, by comparing outcomes in three types of glaucoma surgery.

Conditions

  • Primary Open Angle Glaucoma

Interventions

PROCEDURE

Trabeculectomy

The current standard surgical treatment for glaucoma remains trabeculectomy. Wound healing modulation with antifibrotic agents, like MMC and 5-fluorouracil (5-FU), has been shown to increase the success of glaucoma filtering surgery in high-risk eyes

DEVICE

Baerveldt tube surgery

All glaucoma drainage devices consist of a tube which is inserted into the anterior chamber of the eye, draining aqueous humour to a plate which maintains a minimum bleb size and allows the collection of aqueous humour to be absorbed into the surrounding tissue.

DRUG

mitomycin-C

This is an anti scarring agent whcih is an standard adjunctive treatment in glaucoma surgery

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • K Sheng Lim, MD · Guy's and St Thomas NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT02989207 on ClinicalTrials.gov