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

Not Applicable

Terminated

• Conditions: Diabetic Retinopathy
• Interventions: Procedure: monospot panretinal photocoagulation; Procedure: multispot panretinal photocoagulation

• Registration Number: NCT03242031
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-21
• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-08
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 sessions	monospot panretinal photocoagulation	-
1 session	multispot panretinal photocoagulation	-

Primary Outcome Measures

Name	Time	Method
cost of treatment	9 months after the start of treatment

Trial Locations

Locations (1)

CHU dijon Bourgogne; 🇫🇷 Dijon, France