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

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ClinicalTrials.gov Identifier: NCT01766362
Recruitment Status : Unknown
Verified January 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : January 11, 2013
Last Update Posted : January 11, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Type 1 or 2 With Diabetic Retinopathy. Procedure: PRPC using Pascal laser Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

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

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766362

Contact: Catherine CREUZOT-GARCHER 3 80 29 51 73 ext +33 catherine.creuzot-garcher@chu-dijon.fr

CHU Dijon Recruiting
Dijon, France, 21000
Contact: Catherine CREUZOT-GARCHER    3 80 29 51 73    catherine.creuzot-garcher@chu-dijon.fr   
Principal Investigator: Catherine CREUZOT-GARCHER         
Sub-Investigator: Alain BRON         
CHU de la Croix Rousse Recruiting
Lyon, France, 69004
Contact: Laurent KODJIKIAN    4 26 10 93 21 ext +33      
Principal Investigator: Laurent KODJIKIAN         
Sub-Investigator: Zohra Nacera BOUSSAID         
Hôpital Lariboisière Recruiting
Paris, France, 75475
Contact: Pascale MASSIN    1 49 95 85 44 ext +33      
Principal Investigator: Pascale MASSIN         
Sub-Investigator: Ali ERGINAY         
Sub-Investigator: Zeynep VICTOR         
Sub-Investigator: Sébastien BRUNEAU         
Sub-Investigator: Bénédicte DUPAS         
Sub-Investigator: Julien PEROL         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01766362     History of Changes
Other Study ID Numbers: Creuzot Innov 2010
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Macular Edema
Diabetic Retinopathy
Diabetes Mellitus, Type 1
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Autoimmune Diseases
Immune System Diseases