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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase: Completed; Phase 3

Conditions: Diabetes Type 1 or 2 With Diabetic Retinopathy

Treatments: Procedure: PRPC using Pascal laser

Study type: Interventional

Funder types: Other

Identifiers

NCT01766362

Creuzot Innov 2010

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

A session

Experimental group

Treatment:

Procedure: PRPC using Pascal laser

Four sessions

Other group

Description:

Every session are spaced out of month

Treatment:

Procedure: PRPC using Pascal laser