Medico-economic Comparison Between Treatment with Panretinal Photocoagulation by Laser in 1 Sessi… (NCT03242031) | Clinical Trial Compass
TerminatedNot Applicable
Medico-economic Comparison Between Treatment with Panretinal Photocoagulation by Laser in 1 Session Versus 4 Sessions in Diabetic Retinopathy
Stopped: The promoter decided to stop the study because the rate of enrolment was slowing down due to centres not adhering to the proposed arm.
France48 participantsStarted 2017-06-21
Plain-language summary
Despite the fact that the efficacy of a single session of multispot laser has been demonstrated in the treatment of patients with diabetic retinopathy as compared with four sessions of single-spot laser, the management of panretinal photocoagulation in the different healthcare establishments in France has remained unchanged notably because there is no specific reimbursement for this new treatment protocol.
Although the benefits of reducing the number of sessions and thus the costs associated with the treatment for the patient and the payer seem to be obvious, the medico-economic impact of modifying the treatment strategy thanks to the technological changes must be evaluated to provide deciders with additional information.
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:
* Persons who have provided written informed consent
* Patients with type 1 or 2 diabetes according to World Health Organisation diagnostic criteria.
* Patients with severe non proliferative or early proliferative diabetic retinopathy
* Visual acuity of the treated eye \>= 20/32 snellen (≥ 0.63 Monoyer units or ≥ 70 letters Early treatment Diabetic Retinopathy Study)
* Visual acuity of the contralateral eye \>= 20/200 snellen (≥ 0.10 Monoyer units or ≥ 35 letters Early treatment Diabetic Retinopathy Study)
* Patients with a central macular thickness of 350 μm or less on Spectral Domain - Optical Coherence Tomography
* Patients with national health insurance cover
* Patients over 18 years old
Exclusion Criteria:
* Uncontrolled diabetes in the previous 6 months with intensive insulin therapy (glycated haemoglobin \> 11).
* Uncontrolled hypertension.
* Florid diabetic retinopathy floride.
* Macular oedema due to causes other than diabetic retinopathy or in a context of vitreomacular traction.
* History of intravitreal treatment with anti-angiogenic agent or corticosteroids within the 12 previous months.
* History of treatment with laser in panretinal photocoagulation or focal laser on the treated eye.
* History of eye surgery or laser capsulotomy within the previous 6 months
* History of renal failure requiring dialysis or kidney transplantation for diabetic nephropathy.
* Contra-indication for Tropicamide or Neo-synephrine
* History of uncontrolled glauco…
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.