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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00026156

Enrollment

Registered

2021-10-06

Start date

2021-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H28

Interventions

Group 1: Patients with diagnosed cataract following planed phacoemulsification with implantation of multifocal intraocular lens (MIOL) Acunex Variomax.

Eligibility

Sex/Gender

All

Age

30 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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

Measure	Time frame
-Tomography changes of the anterior segment of the eye (using Pentacam AXL, Oculus) preoperatively and 3 months postoperatively -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 -Contrast sensitivity (using Pelli Robson charts) after 3 months postoperatively -Patient satisfaction using optical quality questionnaire preoperatively and 3 months postoperatively	—

Measure

Time frame

-Tomography changes of the anterior segment of the eye (using Pentacam AXL, Oculus) preoperatively and 3 months postoperatively -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 -Contrast sensitivity (using Pelli Robson charts) after 3 months postoperatively -Patient satisfaction using optical quality questionnaire preoperatively and 3 months postoperatively

—

Countries

Germany

Contacts

Public ContactZubeida Omerovic

Klinik für Augenheilkunde am Klinikum der J.W. Goethe- Universität

Zubeida.HOmerovic@kgu.de069 - 6301 83772

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026