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

Not Applicable

• Conditions: GRAUERSTAR; h25; Senile cataract

• Registration Number: DRKS00003181
• Lead Sponsor: AMO GermanyVertretung für Europa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-02
• Study Completion: 2012-01-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Healthy patients with bilateral cataract; women must not be pregnant or breast-feeding

Exclusion Criteria

uncontrolled systemic or oculare deseases; participation in another study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.