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

  • STATUS
    Recruiting
  • End date
    Mar 20, 2023
  • participants needed
    96
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 20 June 2021
diabetes
retinopathy
diabetic retinopathy
optical coherence tomography
photocoagulation
proliferative diabetic retinopathy

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.

Details
Condition Diabetic Retinopathy, Diabetic Macular Edema
Treatment monospot panretinal photocoagulation, multispot panretinal photocoagulation
Clinical Study IdentifierNCT03242031
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

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 m 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
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