Visual Perception After Virtual Implantation

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Virtual implantation

• Registration Number: NCT04967612
• Lead Sponsor: Carl Zeiss Meditec AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-10
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-19
• Primary Completion: 2021-08-19
• Study Completion: 2021-08-19
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Virtual implantation of diffractive optical lens design A	Virtual implantation	-
Virtual implantation of diffractive optical lens design B	Virtual implantation	-
Virtual implantation of diffractive optical lens design C	Virtual implantation	-

Primary Outcome Measures

Name	Time	Method
Corrected distance visual acuity	during the intervention	Evaluate visual acuity at distance following virtual implantation of diffractive optical lens designs

Trial Locations

Locations (1)

JenVis Research; 🇩🇪 Jena, Germany