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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01766362
First received: January 10, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A session Procedure: PRPC using Pascal laser
Four sessions
Every session are spaced out of month
Procedure: PRPC using Pascal laser

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766362

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

Locations
France
CHU Dijon Recruiting
Dijon, France, 21000
Contact: Catherine CREUZOT-GARCHER    3 80 29 51 73 ext +    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
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01766362     History of Changes
Other Study ID Numbers: Creuzot Innov 2010
Study First Received: January 10, 2013
Last Updated: January 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 22, 2014