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

Diabetic Retinopathy Clinical Trial

— LIGHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03242031
• Other study ID #: CREUZOT PRME 2015
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: March 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Catherine CREUZOT GARCHER, MD
• Phone: 3.80.29.51.73
• Email: catherine.creuzot-garcher[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Procedure:
• monospot panretinal photocoagulation
panretinal photocoagulation with monospot laser
• multispot panretinal photocoagulation
panretinal photocoagulation with multispot laser

Locations

Country	Name	City	State
France	CHU dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cost of treatment		9 months after the start of treatment