DIAMONDS Trial

Trial Acronym DIAMONDS
Clinical Area Ophthalmology
Description Diabetic Macular Oedema and Diode Subthreshold Micropulse Laser (DIAMONDS): A pragmatic, multicentre, allocation concealed, prospective, randomised, non-inferiority double-masked trial
Status ANALYSIS AND REPORTING (22/11/2018)
RECRUITMENT
Date Opened to Recruitment 18th January 2017
Target Recruitment 266
Recruitment 266
Date Closed to Recruitment 20th November 2018
No. of Sites 16
TRIAL DESIGN
Trial Design A pragmatic, multicentre, allocation concealed, prospective, randomised, non-inferiority double-masked trial.
Study Aim To evaluate the clinical effectiveness and cost-effectiveness of Diode Subthreshold Micropulse Laser (DSML), when compared with standard threshold laser, for the treatment of patients with Diabetic Macular Oedema (DMO) with a central retinal subfield thickness of (CST) of < 400 microns.
Objective 1: To determine whether DSML is as good or superior to standard laser at improving or preserving vision at 24 months following treatment in patients with DMO.
Objective 2: To determine whether DSML is as good or superior to standard laser at improving or preserving binocular vision and visual field, reducing / clearing DMO, allowing treated patients to achieve driving standards and improving their health and visual related quality of life at 24 months following treatment. The relative cost-effectiveness of DSML when compared with standard laser will also be evaluated, as well as side effects of these treatments, number of laser treatments required and need for additional treatments (other than laser) for both, DSML and standard laser.
CHIEF INVESTIGATOR (CI)
Chief Investigator Professor Noemi Lois
SPONSOR(s) & FUNDER(s)
Sponsors Belfast Health and Social Care Trust
Funder NIHR Health Technology Assessment Programme (HTA)