Macular edema is the main cause of vision loss in diabetic patients. Its treatment is mainly based on laser photocoagulation, but has limited results. Alternative treatment are under investigation, such as vitrectomy and intravitreal injections of triamcinolone .The aim of VITRILASE is to compare the efficacy of these two treatments to laser photocoagulation for diabetic macular edema.
It is a randomized study with three arms * vitrectomy * repeat intravitreal triamcinolone injections * laser photocoagulation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Vitrectomy
Intravitreal triamcinolone injections
Laser photocoagulation
Pascale MASSIN
Paris, France
Percentage of patients with visual gain ≥ 3 ETDRS lines at 2 years
Time frame: at 2 years
Central macular thickness on Optical Coherence Tomography (OCT)
Time frame: at 8, 12 and 24 months
Percentage of patients with visual gain ≥ 3 ETDRS lines
Time frame: 8, 12 and 22 months
Progression of lens opacities
Time frame: During the all follow-up
Frequency of complications
Time frame: During the all follow-up
Results analysis according to preoperative vitreous detachment, honeycomb macular edema on fluorescein angiography
Time frame: at inclusion time
Evolution of visual fiends and posterior vitreous detachment
Time frame: At inclusion time and 2 years
Percentage of patients presenting an increase of 2 line or more of best corrected visual acuity on ETDRS charts
Time frame: after 1 year, 22 months and 24 months of follow-up
Percentage of patients presenting an decrease of 2 line or more of best corrected visual acuity on ETDRS charts
Time frame: after 1 year, 22 months and 24 months of follow-up
Scores ETDRS
Time frame: after 1 year, 22 months and 24 months of follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mean best corrected visual acuity during follow-up period
Time frame: during the all follow-up
Progression of retinopathy diabetic in each group
Time frame: during the all follow-up
Outcome in respect to posterior vitreal detachment (PVD) stage
Time frame: during the all follow-up
PVD stage evolution during the follow-yp in laser and triamcinolone group
Time frame: first and last exam
Evolution of visual field in each group
Time frame: inclusion and last visit