CompletedPhase 3

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

France83 participantsStarted 2011-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Macular thickness

Timeframe: 9 months after the start of traitement

Trial details

NCT IDNCT01766362

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11

View on ClinicalTrials.gov More Diabetes Type 1 or 2 With Diabetic Retinopathy trials