Medico-economic Comparison Between Treatment with Panretinal Photocoagulation by Laser in 1 Session Versus 4 Sessions in Diabetic Retinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-21

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 session

Group Type EXPERIMENTAL

multispot panretinal photocoagulation

Intervention Type PROCEDURE

panretinal photocoagulation with multispot laser

4 sessions

Group Type ACTIVE_COMPARATOR

monospot panretinal photocoagulation

Intervention Type PROCEDURE

panretinal photocoagulation with monospot laser

Interventions

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monospot panretinal photocoagulation

panretinal photocoagulation with monospot laser

Intervention Type PROCEDURE

multispot panretinal photocoagulation

panretinal photocoagulation with multispot laser

Intervention Type PROCEDURE

Eligibility Criteria

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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 glaucoma or hypertonia
* Patient with aphakia
* Adult under guardianship
* Pegnant or breast-feeding women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No