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Clinical Trials/DRKS00025556
DRKS00025556
Recruiting
未知

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

Dietrich-Bonhoeffer-KlinikumKlinik für Augenheilkunde0 sites30 target enrollmentJuly 20, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
H28
Sponsor
Dietrich-Bonhoeffer-KlinikumKlinik für Augenheilkunde
Enrollment
30
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 20, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Dietrich-Bonhoeffer-KlinikumKlinik für Augenheilkunde

Eligibility 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

  • \- 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

Outcomes

Primary Outcomes

Not specified

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