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One laser session may be as safe as four for diabetic eyes

NCT ID NCT01766362

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

83 people

The number who actually took part.

Started

Oct 2011

Finished

Nov 2015

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • CHU Dijon

    Dijon, 21000, France

  • CHU de la Croix Rousse

    Lyon, 69004, France

  • Hôpital Lariboisière

    Paris, 75475, France

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