PILOT CLINICAL INVESTIGATION OF THE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS, MODEL 1R211R

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2011
INTERVENTION: Intervention 1: The patient will receive the study lens (model 1R211R) into one eye and the control lens (TECNIS® One‐Piece monofocal IOL) into the other eye. This process is randomized. Intervention 2: Patient will receive the study lens into both eyes (model 1R211R). CONDITION: GRAUERSTAR H25 ‐ Senile cataract PRIMARY OUTCOME: The visual acuity of patients will be determined in different distances one and three months after implantation of the IOLs. A questionnaire on the satisfaction of the patients will be filled in. SECONDARY OUTCOME: Advers events according ISO 14155 will be evaluated during the course of the study. During the postoperative examinations after 1 and 3 months, optical‐visual symptoms, lens related and medical complications will be evaluated. A questionnaire for the subjective satisfaction of the patients will be performed. INCLUSION CRITERIA: Healthy patients with bilateral cataract; women must not be pregnant or breast‐feeding
Epistemonikos ID: f467e6a3a91ffda60abb244ff0459ba9ed710c0f
First added on: Aug 22, 2024