One laser session may be as safe as four for diabetic eyes
NCT ID NCT01766362
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 83 people with diabetes and early-stage eye disease. It compared having laser treatment in one session versus four sessions to see which approach better controls the disease and reduces the risk of swelling in the center of the eye. The main goal was to measure the thickness of the central retina 9 months after treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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83 people
The number who actually took part.
- Started
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Oct 2011
- Finished
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Nov 2015
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Dijon
Dijon, 21000, France
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CHU de la Croix Rousse
Lyon, 69004, France
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Hôpital Lariboisière
Paris, 75475, France
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Other studies related to the condition(s) this trial covers.
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