Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2021-05-10
2021-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Virtual implantation of diffractive optical lens design A
Virtual implantation
Temporary placement of virtual optical lens in the crystalline lens plane.
Virtual implantation of diffractive optical lens design B
Virtual implantation
Temporary placement of virtual optical lens in the crystalline lens plane.
Virtual implantation of diffractive optical lens design C
Virtual implantation
Temporary placement of virtual optical lens in the crystalline lens plane.
Interventions
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Virtual implantation
Temporary placement of virtual optical lens in the crystalline lens plane.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Carl Zeiss Meditec AG
INDUSTRY
Responsible Party
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Principal Investigators
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W Sickenberger, Prof
Role: PRINCIPAL_INVESTIGATOR
JenVis Research
Locations
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JenVis Research
Jena, , Germany
Countries
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Other Identifiers
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PJV2002
Identifier Type: -
Identifier Source: org_study_id