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Visual Perception After Virtual Implantation

C

Carl Zeiss Meditec

Status

Completed

Conditions

Healthy

Treatments

Other: Virtual implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04967612
PJV2002

Details and patient eligibility

About

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

Enrollment

74 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

74 participants in 3 patient groups

Virtual implantation of diffractive optical lens design A
Experimental group
Treatment:
Other: Virtual implantation
Virtual implantation of diffractive optical lens design B
Experimental group
Treatment:
Other: Virtual implantation
Virtual implantation of diffractive optical lens design C
Experimental group
Treatment:
Other: Virtual implantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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