Visual Perception After Virtual Implantation

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967612
• Other study ID #: PJV2002
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: August 19, 2021

Study information

• Verified date: October 2021
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 19, 2021
• Est. primary completion date: August 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Virtual implantation
Temporary placement of virtual optical lens in the crystalline lens plane.

Locations

Country	Name	City	State
Germany	JenVis Research	Jena

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected distance visual acuity	Evaluate visual acuity at distance following virtual implantation of diffractive optical lens designs	during the intervention