Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.

Study Overview
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Brief Summary
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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.

Official Title
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Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.

Conditions
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Diabetes Type 1 or 2 With Diabetic Retinopathy

Intervention / Treatment
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* Procedure: PRPC using Pascal laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A session<br> | Procedure: PRPC using Pascal laser<br> <br> |
| Other: Four sessions<br>Every session are spaced out of month | Procedure: PRPC using Pascal laser<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular thickness | Central macular thickness at 9 months after the start of PRPC using Pascal laser. | 9 months after the start of traitement |