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OpenTrials
Completed

NCT Number: NCT01766362

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Dijon, Dijon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRPC using Pascal laser

Procedure

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: Pascal

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 11, 2013
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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