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

University Hospital Center (CHU) Dijon Bourgogne

Status

Terminated

Conditions

Diabetic Retinopathy

Treatments

Procedure: monospot panretinal photocoagulation

Procedure: multispot panretinal photocoagulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03242031

CREUZOT PRME 2015

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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