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ILM PEELING and/or Triamcinolone in Persistent Diabetic Macular Edema (TIME-Study)

Joussen A. M., Kirchhof B.,
Universität zu Köln, Zentrum für Augenheilkunde, Abteilung für Netzhaut- und Glaskörperchirurgie (Köln)

Patients: Patients with persistent macular edema as a consequence of diabetic maculopathy
Treatments: Group 0: Observation: in this group the lens status will be determined according to LOCS 3 at each visit. In case of deterioration of V/A as a consequence of cataract formation, cataract surgery and IOL implantation will be performed TRIAMCINOLONE (4MG) INTRAVITREAL AND/OR ILM PEELING: All patients will undergo cataract surgery and IOL implantation at the time of the operation: Group 1: ppV and posterior vitreous detachment; Group 2: ppV and posterior vitreous detachment + ILM peeling; Group 3: ppV and posterior vitreous detachment and ILM peeling + triamcinolone 4 mg at time of surgery and after every visit (8 weekly); Group 4: triamcinolone 4 mg at every visit (8 weekly).
Inclusion Criteria: Persistent (diffuse or focal) macular edema (>6 month) as demonstrated by fluorescein angiography according to ETDRS criteria for CSME associated with diabetes
Exclusion Criteria: ischemic maculopathy (foveal avascular zone > 800 µm according to grade 3 ETDRS); proliferative retinopathy and associated complications such as bleeding and tractional detachment (ADED); additional ocular diseases reducing the visual acuity: retinal artery occlusion, glaucoma in a late stage, mature cataract, choriodal neovascularization, uveitis; age <18; cataract surgery less than twelve month before treatment· known cortico-steroid responder; complications during surgery requiring endotamponade; change of current long-term treatment with vasoactive substances such as non-steroidal antiinflammatory drugs or steroids
Examinations: Measurement of visual acuity, reading speed, contrast sensivity, colour vision; fluorescein angiography of the retinal vasculature; stereo fundus photography; retinal thickness measurement with optical coherence tomography (OCT); quality of life questionnaire
Primary Endpoint: 2 month distant visual acuity (ETDRS), · 12 month distand visual acuity (ETDRS)
Secondary Endpoint: 2, 4, 6, 12 month visual acuity; reading performance at 2, 4, 6 and 12 month (Radner-Test); changes in retinal thickness as measured by OCT at all time points; determination of vascular leakage by fluorescein angiography at all time points; quality of life questionnaire; contrast sensitivity, colour vision; long term glucose control (HbA1c), Type I or Type II diabetes, insulin treatment
Principal clinical Investigators: Priv.-Doz. Dr. Antonia M. Joussen, Köln; Prof. Dr. Bernd Kirchhof, Köln
Status: Ethics comittee: applied; Funding: Application in preparation; Study centers/physicians: still open