Study Stopped
The promoter decided to stop the study because the rate of enrolment was slowing down due to centres not adhering to the proposed arm.
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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2017
CompletedFirst Submitted
Initial submission to the registry
August 4, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedOctober 16, 2024
October 1, 2024
5.2 years
August 4, 2017
October 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
cost of treatment
9 months after the start of treatment
Study Arms (2)
1 session
EXPERIMENTAL4 sessions
ACTIVE COMPARATORInterventions
panretinal photocoagulation with monospot laser
panretinal photocoagulation with multispot laser
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU dijon Bourgogne
Dijon, 21079, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2017
First Posted
August 8, 2017
Study Start
June 21, 2017
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
October 16, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share