Visual Perception After Virtual Implantation

NCT04967612 | Completed

• 1 other identifier: PJV2002
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Corrected distance visual acuity

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

  during the intervention

Study Arms (3)

Virtual implantation of diffractive optical lens design A

EXPERIMENTAL

Other: Virtual implantation

Virtual implantation of diffractive optical lens design B

EXPERIMENTAL

Other: Virtual implantation

Virtual implantation of diffractive optical lens design C

EXPERIMENTAL

Other: Virtual implantation

Interventions

Virtual implantation OTHER

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

Virtual implantation of diffractive optical lens design A; Virtual implantation of diffractive optical lens design B; Virtual implantation of diffractive optical lens design C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

JenVis Research

Jena, 07745, Germany

Location

Study Officials

• W Sickenberger, Prof

  JenVis Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 19, 2021
• Study Start: May 10, 2021
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

DE (1)