Status:
TERMINATED
Medico-economic Comparison Between Treatment with Panretinal Photocoagulation by Laser in 1 Session Versus 4 Sessions in Diabetic Retinopathy
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 las...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03242031
Start Date
June 21 2017
End Date
August 31 2022
Last Update
October 16 2024
Active Locations (1)
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1
CHU dijon Bourgogne
Dijon, France, 21079