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CompletedNCT01766362PascalUpdated Feb 9, 2026

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

A Phase 3 interventional study of PRPC using Pascal laser in Diabetes Type 1 or 2 With Diabetic Retinopathy, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Centre Hospitalier Universitaire Dijon · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2011, registered Jan 2013).
Phase
Phase 3
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Diabetes Type 1 or 2 With Diabetic Retinopathy
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In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 83 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    A session

    Procedure: PRPC using Pascal laser

  • Other
    Four sessions

    Every session are spaced out of month

    Procedure: PRPC using Pascal laser

Interventions

  • ProcedurePRPC using Pascal laser
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What researchers measure

Primary outcomes

  1. Macular thickness

    Central macular thickness at 9 months after the start of PRPC using Pascal laser.

    Time frame: 9 months after the start of traitement

07

Study locations

3 sites
  • CHU Dijon
    Dijon, 21000, France
  • CHU de la Croix Rousse
    Lyon, 69004, France
  • Hôpital Lariboisière
    Paris, 75475, France
08

References and documents

Publications

  • Gabrielle PH, Massin P, Kodjikian L, Erginay A, Pallot C, Jonval L, Soudry A, Couturier A, Vardanian-Vartin C, Bron AM, Creuzot-Garcher C. Central retinal thickness following panretinal photocoagulation using a multispot semi-automated pattern-scanning laser to treat ischaemic diabetic retinopathy: Treatment in one session compared with four monthly sessions. Acta Ophthalmol. 2019 Aug;97(5):e680-e687. doi: 10.1111/aos.14002. Epub 2018 Dec 18. PubMed 30561087 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01766362
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Jan 11, 2013
Start date
Oct 2011
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Feb 9, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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