MEMManchester Pascal Endpoint Management Laser Treatment of Diffuse Diabetic Macular Oedema (DMO): A Safety and Efficacy Study

Fecha de inicio: 1 de octubre de 2012

Inclusion Criteria: Patient-eligibility Inclusion criteria: 1. Older than 18 years of age 2. Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes 3. Able to give informed consent Study Eye eligibility Inclusion criteria: 1. ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 20/200 or better) 2. The patient must have non-proliferative diabetic retinopathy (NPDR) with diffuse macular oedema 3. Mean average central retinal thickness at least 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans 4. 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 5. Ability to perform accurate Humphmrey visual field test Exclusion Criteria: Patient-eligibility Exclusion criteria: 1. History of chronic renal failure or renal transplant for diabetic nephropathy 2. Recent (last 6 months) or on-going poor glycaemic control. H1Ac greater than 10.0mg/dL 3. Creatinine greater than 1.2 mg/dL 4. HDL equal to or greater than 40 mg/dL 5. Uncontrolled hypertension. Blood pressure greater or equal to 180/110 mmHg 6. Patient is unavailable for follow-up visits 7. Pregnant women or breast-feeding females Study Eye eligibility Exclusion criteria: 1. Lens opacity that could influence vision and results 2. Proliferative Diabetic Retinopathy. 3. Any surgical or non-retinal laser treatment to the study eye within 2 months 4. Narrow drainage angles with raised intraocular pressure and angle closure glaucoma. 5. Planned YAG peripheral iridotomy 6. Previous retinal laser photocoagulation, intraocular drug therapy, or macular laser treatment to treatment eye in last year 7. Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment. 8. Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ. 9. Any previous ocular condition that may be associated with a risk of macular edema 10. Important known allergies to sodium fluorescein dye used in angiography. 12\. Active lid or adnexal infection 13. Planned intra-ocular surgery within one year