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Clinical Trials/DRKS00026156
DRKS00026156
Recruiting
Phase 4

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

Teleon Surgical B.V.0 sites17 target enrollmentOctober 6, 2021
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ConditionsH28Cataract and other disorders of lens in diseases classified elsewhere

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
H28
Sponsor
Teleon Surgical B.V.
Enrollment
17
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 6, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Teleon Surgical B.V.

Eligibility Criteria

Inclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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