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OpenTrials
Completed

NCT Number: NCT04967612

Visual Perception After Virtual Implantation

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JenVis Research

Jena, 07745, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • Hyperopes with more than +6 D refraction.

Treatment and study plan

Virtual implantation

Other

Temporary placement of virtual optical lens in the crystalline lens plane.

Primary outcomes

  1. Corrected distance visual acuity

    Time frame: during the intervention

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

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2021
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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