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

Primary Purpose

Diabetic Retinopathy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
monospot panretinal photocoagulation
multispot panretinal photocoagulation
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 session

4 sessions

Arm Description

Outcomes

Primary Outcome Measures

cost of treatment

Secondary Outcome Measures

Full Information

First Posted
August 4, 2017
Last Updated
June 8, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT03242031
Brief Title
Medico-economic Comparison Between Treatment With Panretinal Photocoagulation by Laser in 1 Session Versus 4 Sessions in Diabetic Retinopathy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 session
Arm Type
Experimental
Arm Title
4 sessions
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
monospot panretinal photocoagulation
Intervention Description
panretinal photocoagulation with monospot laser
Intervention Type
Procedure
Intervention Name(s)
multispot panretinal photocoagulation
Intervention Description
panretinal photocoagulation with multispot laser
Primary Outcome Measure Information:
Title
cost of treatment
Time Frame
9 months after the start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine CREUZOT GARCHER, MD
Phone
3.80.29.51.73
Ext
+33
Email
catherine.creuzot-garcher@chu-dijon.fr
Facility Information:
Facility Name
CHU dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine CREUZOT GARCHER, MD
Phone
3.80.29.51.73
Ext
+33
Email
catherine.creuzot-garcher@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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