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

Medico-economic Evaluation of Treatment with Panretinal Photocoagulation in One Session Using Multispot Laser Versus Four Sessions Using Single-spot Laser in Patients with Severe Non-proliferative and Early Proliferative Diabetic Retinopathy

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Procedure: multispot panretinal photocoagulation; Procedure: monospot panretinal photocoagulation

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 session	Procedure: multispot panretinal photocoagulation; panretinal photocoagulation with multispot laser
Active Comparator: 4 sessions	Procedure: monospot panretinal photocoagulation; panretinal photocoagulation with monospot laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cost of treatment	9 months after the start of treatment

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: CREUZOT PRME 2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No