gms | German Medical Science

The examination plan and first experiences of the Dexapos N^® study are presented. In a multicenter clinical double-blind phase III- study 210 patients are examined in 7 centres to the antiinflammatory effectiveness and tolerance of Dexapos N^® eye drops after phacoemulsification with implantation of a posterior chamber lens. Dexa-sine^® eye drops are used as the reference medication. Both medications contain 1mg/ml of dexamethasondi-hydrogenphosphate. In addition, the patients received Polyspectran^® eye drops as antibiotic.

Main criterion is the decrease of the inflammation symptoms measuring the Tyndall value by the Laser-Flare-Meter LFM 500 (Fa. Kowa), the assessment of the inflammation status by a visual analogous scale, the influence to the inflammation status of the eye by assessment of conjunctiva and cornea, the measurement of the intraocular pressure and the visual acuity. Also the compliance of the patient is assessed by the ophthalmologist. The patients are examined before surgery and on the first, third, seventh and fourteenth day after surgery. The tolerance is assessed clinically and by a questionnaire performed by the patient. The patients immediately after surgery get one eye drop of the examination medication and one drop of Polyspectran^® and the next drops in the evening after surgery. In the first week the examination medication and the Polyspectran^® eye drops are given five times daily, in the second week four times daily.

Exclusion criteria in this study are eye illnesses as cornea guttata, pseudoexfoliation syndrome or status post vitreal surgery, therefore illnesses delaying the healing process or increasing the Tyndall in the anterior chamber. Patients are excluded in case of allergic reaction or complications during or after surgery (yet one bleeding in the anterior chamber). The study was approved July 7^th 2003 by the ethic committee of the medical faculty of the Martin-Luther university of Halle-Wittenberg and examination was started October 10^th 2003. The examination is sponsored by Ursapharm in Saarbrücken. The study is conducted by the university of Halle-Wittenberg. 30 patients will be examined in every centre. In the university of Halle 15 patients are included yet. The study should be completed in 2004.