Retro- and prospective, single-center PMCF * study to check vision, contrast vision and patient satisfaction after bilateral implantation of the SBL-2 ™ - a multifocal IOL from Afidera

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025556

Enrollment

Registered

2021-07-20

Start date

2021-05-03

Completion date

Unknown

Last updated

2026-06-22

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 treated with the SBL-2 on both sides as part of the cataract operation

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients = 50 years of age - Surgery has already been carried out in both eyes with implantation of the same lens type on both eyes (SBL-2, Afidera GmbH, Berlin) - Implantation of the IOL in the capsular bag - Willingness to participate in the study with a written declaration of consent - Refractive power of the lens between 10.5 and 29.5 D, in 0.5 D gradations - Refractive power of the lens between 15.25 and 24.75 D, in 0.25 D gradations

Exclusion criteria

Exclusion criteria: - amblyopia, strabismus - Astigmatism = 1 dpt - Pathology of the cornea and retina - Diseases of the eye which, in addition to the pre-existing cataract, can lead to a reduction in visual acuity to 0.5 or worse - intraoperative complications

Design outcomes

Primary

Measure	Time frame
What is the mean distance corrected visual acuity for the intermediate area for the SBL-2	—

Secondary

Measure	Time frame
How high is the tolerance for the patient for the distance, the intermediate area and the proximity	—

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: Jun 27, 2026