Follow-up and evaluation of functional visual results after implantation of the multifocal intraocular lens Acunex VarioMax

Phase 4

Recruiting

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

Registration Number: DRKS00026156

Lead Sponsor: Teleon Surgical B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 17

Inclusion Criteria

• Cataract
• Patients aged 30 years and older
• Bilateral intervention
• Corneal astigmatism up to = +0.75 D postoperatively (4mm TCRP, Pentacam AXL)
• Planned implantation in the capsular bag
• Planned implantation of the Acunex VarioMax
• 3 mm = low mesopic pupil size (Procyon, 0.04 lux) = 6 mm
• Pupil decentering <1 mm (Center Shift, Pentacam AXL)
• Contact lens waiting period of at least 2 weeks (soft contact lenses) / 6 weeks (hard contact lenses) before the preoperative examination
• Written informed consent from the patient, ability of the patient to understand the purpose and implications of this study.

Exclusion Criteria

• Last eye (oculus ultimus)
• Amblyopia
• Strabismus
• Irregular astigmatism
• Diseases or previous surgery on an eye other than cataract that, in the investigator's judgment, could result in a decrease in decimal visual acuity of 0.5 or worse
• Previous corneal refractive interventions

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corrected and uncorrected visual acuity in far (4m), intermediate (80 cm) and near (40 cm) distance using ETDRS (Early Treatment of Diabethic Retinopathia Study) charts.<br><br>For each patient both eyes are examined. The visual acuity data are collected preoperatively and 1 week, 1 and 3 months after cataract surgery.

Secondary Outcome Measures

Name	Time	Method
-Tomography changes of the anterior segment of the eye (using Pentacam AXL, Oculus) preoperatively and 3 months postoperatively<br><br>-Binocular defocus curve between -4.0 D and +2.0 D (in 0.5 D steps) using ETDRS (Early Treatment of Diabethic Retinopathia Study) charts after 3 months postoperatively<br><br>-Contrast sensitivity (using Pelli Robson charts) after 3 months postoperatively<br><br>-Patient satisfaction using optical quality questionnaire preoperatively and 3 months postoperatively