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

Phase 3

Completed

• Conditions: Diabetes Type 1 or 2 With Diabetic Retinopathy
• Interventions: Procedure: PRPC using Pascal laser

• Registration Number: NCT01766362
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Four sessions	PRPC using Pascal laser	Every session are spaced out of month
A session	PRPC using Pascal laser	-

Primary Outcome Measures

Name	Time	Method
Macular thickness	9 months after the start of traitement	Central macular thickness at 9 months after the start of PRPC using Pascal laser.

Trial Locations

Locations (3)

CHU Dijon; 🇫🇷 Dijon, France

CHU de la Croix Rousse; 🇫🇷 Lyon, France

Hôpital Lariboisière; 🇫🇷 Paris, France