Prospective, single-center PMCF * study to check the IOL constant with recording of vision, contrast vision and patient satisfaction after bilateral implantation of a glistening-free, hydrophobic, multifocal IO

Phase 4

Conditions: H28
Cataract and other disorders of lens in diseases classified elsewhere

Registration Number: DRKS00023571

Lead Sponsor: Teleon Surgical Van Rensselaerweg 4bNL- 6956 AV Spankeren Teleon Surgical Vertriebs GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 23

Inclusion Criteria

patient age> 30 years
- Bilateral cataract / bilateral supply
- expected postoperative corneal astigmatism = 1.00 dpt
- Planned implantation in the capsular bag
- photopic pupil size = 2.8 mm
- Pupil decentering <0.8 mm (center shift)
- Contact lens break of at least 2 weeks
- a written declaration of consent of the patient

Exclusion Criteria

- amblyopia, strabismus
- Irregular Corneal Astigmatism Pathology of the cornea and retina
- Diseases of the eye which, apart from the cataract, can lead to a reduction in the decimal visual acuity to 0.63 or worse
- intraoperative complications
- current active participation in another clinical study of the patient

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main question:<br>1. How accurate is the IOL constant for calculating the lens power. The postoperative residual ametropia is determined up to 12 months after the operation by means of objective refraction. This results in the deviation from the target refraction and, accordingly, the accuracy of the preoperative calculation with the A constant.<br>2. What is the mean distance-corrected visual acuity for the intermediate and near areas for the Acunex VarioMax? After 6 and 12 months, the visual acuity has to be checked with the distance correction in the intermediate and near areas. Depending on the extent of the possible decrease in visual acuity in the near areas, the distance at which the patient can read without glasses and the percentage of patients who can read without glasses is determined.

Secondary Outcome Measures

Name	Time	Method
Secondary question:<br>How high is the patient satisfaction?<br>On the basis of questionnaires, 12 months postoperatively, satisfaction for visual tasks in everyday life, in twilight vision and possible glare is determined.