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

February 5, 2026 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Chu Dijon
      • Lyon, France, 69004
        • CHU de la Croix Rousse
      • Paris, France, 75475
        • Hôpital Lariboisière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

January 10, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimated)

January 11, 2013

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Creuzot Innov 2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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