Macular edema remains a major cause of vision impairment in diabetic patients. Its pathogenesis is multifactorial and incompletely understood. Systemic factors seam to play a role in this pathogenesis, including high blood pressure. The objective of the study is to evaluate the effect of an intensified intervention on blood pressure and sleep apnea with that of conventional treatment in patients with type 2 diabetes and diabetic macular edema.
Patients with type 2 diabetes and macular edema involving the center of the macula in both eyes will be randomly assigned to receive conventional treatment in accordance with national guidelines or to receive intensive treatment, with a systematic screening for sleep apnea and /or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected. The primary outcome will be the percentage of patients having a sustained 50% or more-decrease in retinal thickening at 1 year. Secondary outcomes will be the percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year, number of ocular interventions in each group, prevalence of sleep apnea and uncontrolled high blood pressure in the intervention group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
over one 14 month period: strongly recommended hygiene-dietetic measurements, complete assessment with ambulatory measurement of the blood pressure in D0, 3 and 12 months, a therapeutic strategy according to the results, and control every 3 months
over one 14 month period: complete assessment with night polysomnography in D0, 3 and 12 months, a therapeutic strategy according to the results, and control every 3 months
over one 14 month period: control every 3 months, treatments by laser (focal or grid) are authorized until 9 months, treatments by injections are authorized until 6 months
Service d'ophtalmologie, Hôpital de la Vision, La Timone
Marseille, Bouches du Rhone, France
Service d'Ophtalmologie, Hôtel Dieu
Nantes, Loire Atlantique, France
Service d'Ophtalmologie, Hôpital Avicenne
Bobigny, Île-de-France Region, France
Hôpital Lariboisière, service d'Ophtalmologie
Paris, Île-de-France Region, France
The primary outcome will be the percentage of patients having a sustained 50% or more-decrease in retinal thickening at 1 year, assessed with OCT in the study eye.
Time frame: M13
Percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year in the study eye
Time frame: M13
Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye
Time frame: M6-9
Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye
Time frame: M13
Comparison of blood pressure in each group at one year
Time frame: M13
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Service d'Ophtalmologie IV, Hôpital des XV-XX
Paris, Île-de-France Region, France