Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
NCT ID: NCT01766362
Last Updated: 2018-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
83 participants
INTERVENTIONAL
2011-10-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A session
PRPC using Pascal laser
Four sessions
Every session are spaced out of month
PRPC using Pascal laser
Interventions
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PRPC using Pascal laser
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon
Dijon, , France
CHU de la Croix Rousse
Lyon, , France
Hôpital Lariboisière
Paris, , France
Countries
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Other Identifiers
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Creuzot Innov 2010
Identifier Type: -
Identifier Source: org_study_id