Healthy
Conditions
Brief summary
Evaluation of visual perception through diffractive optical lens designs by virtual implantation.
Interventions
OTHERVirtual implantation
Temporary placement of virtual optical lens in the crystalline lens plane.
Sponsors
Carl Zeiss Meditec AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corrected distance visual acuity | during the intervention | Evaluate visual acuity at distance following virtual implantation of diffractive optical lens designs |
Countries
Germany
Outcome results
None listed