Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session… (NCT01766362) | Clinical Trial Compass
CompletedPhase 3
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
France83 participantsStarted 2011-10
Plain-language summary
The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diabetes type 1 or 2
* Subjects with severe non-proliferative or early proliferative diabetic retinopathy (according to the Alfediam classification)
* Subjects with central macular thickness less than or equal to 350 µm according to spetralis OCT
* Subjects registered with a social security agency
* Subjects who have provided written informed consent
* Subjects aged 18 or above
Exclusion Criteria:
* Pregnancy
* Breastfeeding women
* Patients presenting a contra-indication to Mydriaticum and Neosynephrine
* History of glaucoma or non-controlled ocular hypertension
* Blindness in one eye
* History of renal insufficiency requiring dialysis, or kidney or pancreas transplantation
* Unbalanced diabetes requiring, in the previous 4 months, intensive insulin therapy.
* Central macular thickness greater than 350 µm
* Visual acuity less than 20/32 measured using an ETDRS chart
* Proliferative diabetic retinopathy associated with "high risk factors" (extensive prepapillary neovessels and/or preretinal or prepapillary neovessels associated with preretinal of intravitreal hemorrhage)
* Macular edema due to causes other than diabetic retinopathy (venous occlusion, uveitis) or occurring in a context of vitreomacular traction
* Already started PRPC
* History of eye surgery or YAG laser capsulotomy performed during the preceding 6 months
* Subjects under legal supervision or guardianship