NCT Number: NCT01766362
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
CHU Dijon, Dijon, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire Dijon
Other
Registry information
Acronym: Pascal
Important dates
- Study start
- 2011
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jan 11, 2013
- Registry last updated
- Feb 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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