Pilot Study - Primary glaucoma surgery for patients of African Descent
Research type
Research Study
Full title
Comparing surgical approaches to treat black African and African-Caribbean patients with uncontrolled primary open angle glaucoma: A randomised feasibility study
IRAS ID
160807
Contact name
K. Sheng Lim
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, days
Research summary
It has been estimated that the risk of glaucoma amongst African Americans is four times that of white Europeans of the same age. The current first line treatment for Primary Open Angle Glaucoma (POAG) that is uncontrolled on tolerated medical therapy (eye drops) is trabeculectomy surgery performed after the application of the anti-scarring agent Mitomycin C (MMC). However, one study has found that the risk of failure after trabeculectomy was 79% greater for black people compared with white people. \n\nThe 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 Baerveldt tube surgery for glaucoma in comparison to trabeculectomy. However, this study did not address black populations specifically and did not address the potential role of MMC in tube surgery.\n\nOur aim is to perform a single site randomised feasibility trial to inform the design and conduct of a proposed large scale multi site prospective RCT comparing clinical effectiveness and health economic outcomes for three surgical methods to treat uncontrolled POAG in black African and African-Caribbean patients: trabeculectomy with MMC, Baerveldt tube surgery with MMC and Baerveldt tube surgery without MMC. This feasibility study will enable us to design a fully powered RCT with the aim of comparing outcomes in these three types of glaucoma surgery so as to provide a definitive answer as to which approach is most favoured in this population.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
15/LO/1810
Date of REC Opinion
16 Feb 2016
REC opinion
Further Information Favourable Opinion