Sub-threshold Photocoagulation of Diabetic Macular Oedema
Stopped: The PI decided to close the study early as patients with diffused macular oedema without any previous treatment are uncommon.
United Kingdom0Started 2012-10
Plain-language summary
Topcon's Endpoint Management (EM) is a new software from the Pascal® laser which allows us to decrease the intensity of the burns (invisible burns) showing some landmarks with normal intensity so the investigators can see the area which has been treated. The Pascal® system with EM utilizes 577nm laser wavelength compared to the 532nm laser wavelength which was utilized in previous Pascal® laser studies.
This study aims to demonstrate that 577nm Pascal® with EM has the same efficacy and effectiveness as 532nm Pascal® in the treatment of diabetic macular oedema.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Older than 18 years of age
âś“. Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes
âś“. Able to give informed consent
âś“. ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 20/200 or better)
âś“. The patient must have non-proliferative diabetic retinopathy (NPDR) with diffuse macular oedema
âś“. Mean average central retinal thickness at least 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans
âś“. Adequate pupil dilatation and clear media to perform wide-field colour, red-free imaging and fundus fluorescein angiography (WF-FFA), wide-field fundus autofluorescence imaging (WF-AF) and DRI-OCT
âś“. Ability to perform accurate Humphmrey visual field test
Exclusion criteria
âś•. History of chronic renal failure or renal transplant for diabetic nephropathy
What they're measuring
1
reduction of diabetic macular edema (central retinal thickness) within the 6 arms of the study