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Clinical Trials/NCT04967612
NCT04967612
Completed
Not Applicable

Evaluation of Visual Perception Through Diffractive Optical Lens Designs by Virtual Implantation.

Carl Zeiss Meditec AG1 site in 1 country74 target enrollmentMay 10, 2021
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Carl Zeiss Meditec AG
Enrollment
74
Locations
1
Primary Endpoint
Corrected distance visual acuity
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Evaluation of visual perception through diffractive optical lens designs by virtual implantation.

Registry
clinicaltrials.gov
Start Date
May 10, 2021
End Date
August 19, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female subjects between and including 18 and 50 years of age;
  • Healthy eyes;
  • Dominant eye with a monocular CDVA ≥1.0 decimal (≤ 0.0 logMAR) without cycloplegia;
  • Subject who has been informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
  • Negative COVID19 screening test prior to every trial visit.

Exclusion Criteria

  • Subjects of less than 18 or more than 50 years of age;
  • Monocular CDVA of dominant eye \< 1.0 decimal (\> 0.0 logMAR) without cycloplegia;
  • Subject unable to comply with the study protocol or likely to be non-cooperative during the study;
  • Subject whose freedom is impaired by administrative or legal issues, or adult persons under legal protection or unable to give an informed consent;
  • Pseudophakic subjects;
  • Subjects, who are unable to fixate for a longer time, e.g. strabismus, nystagmus;
  • Pathologic miosis;
  • Intake of drugs affecting vision;
  • Participation in another biomedical study in parallel, if it affects vision or if interactions with cycloplegia exist;
  • Intolerance to or contraindication to cycloplegia, e.g. due to narrow angle of the anterior ocular chamber;

Outcomes

Primary Outcomes

Corrected distance visual acuity

Time Frame: during the intervention

Evaluate visual acuity at distance following virtual implantation of diffractive optical lens designs

Study Sites (1)

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