- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01766362
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients. (Pascal)
December 26, 2018 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
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
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Dijon, France, 21000
- CHU Dijon
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Lyon, France, 69004
- CHU de la Croix Rousse
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Paris, France, 75475
- Hopital Lariboisiere
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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
Genders Eligible for Study
All
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A session
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Other: Four sessions
Every session are spaced out of month
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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
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Central macular thickness at 9 months after the start of PRPC using Pascal laser.
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9 months after the start of traitement
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimate)
January 11, 2013
Study Record Updates
Last Update Posted (Actual)
December 27, 2018
Last Update Submitted That Met QC Criteria
December 26, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Diabetes Mellitus, Type 1
- Diabetic Retinopathy
- Macular Edema
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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Clinical Trials on PRPC using Pascal laser
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Manchester University NHS Foundation TrustTopcon Corporation; Optos, PLCWithdrawnDiabetic Macular OedemaUnited Kingdom
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Kocatepe UniversityCompleted
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L.V. Prasad Eye InstituteUnknownDiabetic Retinopathy | Macular Edema | Visual Field LossIndia
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Stanford UniversityBascom Palmer Eye InstituteCompletedMacular Degeneration | Retinal DrusenUnited States
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Asociación para Evitar la Ceguera en MéxicoUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyMexico
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Medical University of ViennaCompletedMacular Edema | Proliferative Diabetic RetinopathyAustria
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The Lowy Medical Research Institute LimitedActive, not recruiting
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University Hospital OstravaCompletedDiabetic Retinopathy
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National University Hospital, SingaporeCompleted
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Asociación para Evitar la Ceguera en MéxicoCompletedBruch Rupture | Choroidal DetachmentMexico