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 IOL

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 IOL - ACUNEX-Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023571

Enrollment

Registered

2020-12-11

Start date

2020-10-01

Completion date

Unknown

Last updated

2025-10-06

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 who undergo phacoemulsification with implantation of the MF-IOL Acunex Variomax multifocal intraocular lens with a diagnosed cataract.

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main question: 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. 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.	—

Measure

Time frame

Main question: 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. 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

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

Countries

Germany

Contacts

Public ContactUlrike Holland

Diakonie Klinikum Dietrich Bonhoeffer GmbH

aug-st2@dbknb.de0395/775-13427

Outcome results

None listed

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