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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive treatment | Experimental | with a systematic screening for sleep apnea and/or uncontrolled high blood pressure, and intensified intervention on both anomalies if detected |
|
| conventional treatment | Active Comparator | in accordance with national guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high blood pressure treatment | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | M13 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients having a 2 ETDRS lines or more-increase in visual acuity at one year in the study eye | M13 | |
| Number of ocular interventions (laser photocoagulation, intra ocular injections) in each group at one year in the study eye | M6-9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascale MASSIN, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'ophtalmologie, Hôpital de la Vision, La Timone | Marseille | Bouches du Rhone | 13005 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16303968 | Background | Paques M, Massin P, Sahel JA, Gaudric A, Bergmann JF, Azancot S, Levy BI, Vicaut E. Circadian fluctuations of macular edema in patients with morning vision blurring: correlation with arterial pressure and effect of light deprivation. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4707-11. doi: 10.1167/iovs.05-0638. |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D012891 | Sleep Apnea Syndromes |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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|
| sleep apnea treatment | Behavioral | 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 |
|
| diabetic macular edema treatment | Behavioral | 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 |
|
| Progression of diabetic retinopathy in each group at one year according to the International DR classification in the study eye | M13 |
| Comparison of blood pressure in each group at one year | M13 |
| Service d'Ophtalmologie, Hôtel Dieu |
| Nantes |
| Loire Atlantique |
| 44093 |
| France |
| Service d'Ophtalmologie, Hôpital Avicenne | Bobigny | Île-de-France Region | 93009 | France |
| Hôpital Lariboisière, service d'Ophtalmologie | Paris | Île-de-France Region | 75010 | France |
| Service d'Ophtalmologie IV, Hôpital des XV-XX | Paris | Île-de-France Region | 75012 | France |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |