Panretinal Photo-stimulation in Proliferative Diabetic Retinopathy
United Kingdom0Started 2012-10
Plain-language summary
Diabetic retinopathy (DR) is a leading cause of new cases of blindness in people aged 20 to 65 years worldwide.
Patients with DR may go on to develop a more severe form of the disease called Proliferative Diabetic Retinopathy (PDR), a condition in which abnormal new blood vessels may rupture and bleed inside the eye. When this advanced stage of retinopathy occurs, pan-retinal photocoagulation (laser treatment) is usually recommended.
The purpose of the investigators study is to find if treating patients using a single session of lower intensity laser (Pascal® Pan Retinal Photo-Stimulation, P-RPhS) at an earlier stage in Diabetic Retinopathy (during the severe non-proliferative diabetic retinopathy stage) when the abnormal new vessels are not developed, will prevent diabetic patients to develop PDR.
Patients included in the study will be randomized in three arms (randomization). In one arm patients will be treated with the normal parameters used in Pascal® laser, the second arm patients will be treated with a lower intensity than normal, using the Endpoint management system (a new software from the Pascal® laser which allow us to decrees the intensity of the burns (invisible burns) showing some landmarks with normal intensity so the area which has been treated can be viewed. And in the third arm the patients will be observed.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Older than 18 years of age
✓. Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes
✓. Able to give informed consent
✓. Treatment-naive S-NPDR
✓. ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 6/60 or better)
✓. Any of the following:
✓. Mean central retinal thickness of less than or equal to 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans
✓. No intra-retinal fluid (IRF) or sub-retinal fluid (SRF) on DRI-OCT
Exclusion criteria
✕. History of chronic renal failure or renal transplant for diabetic nephropathy
✕. Recent (last 6 months) or on-going poor glycaemic control. H1Ac greater than 10.0mg/dL
What they're measuring
1
prevention on the developing of proliferative diabetic retinopathy (assessed with slitlamp, color fundus, and fluorangiography)