| Trial Acronym | DIAMONDS |
| Clinical Area | Ophthalmology |
| Trial Title | Diabetic Macular Oedema and Diode Subthreshold Micropulse Laser (DIAMONDS): A pragmatic, multicentre, allocation concealed, prospective, randomised, non-inferiority double-masked trial |
| Status | Closed |
| Trial Registration | https://www.isrctn.com/ISRCTN17742985 |
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Recruitment
Recruitment Target 266 Date Open to Recruitment January 2017 Recruitment 266 Date Closed to Recruitment November 2018 -
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
Chief Investigator Professor Noemi Lois, Queen’s University Belfast -
Sponsor & Funder
Sponsors Belfast Health and Social Care Trust Funder National Institute for Health and Care Research, Health Technology Assessment Programme (HTA)