| 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. |
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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. |
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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. |
