Visual Perception After Virtual Implantation

NCT ID: NCT04967612

Last Updated: 2021-10-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2021-08-19

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Virtual implantation of diffractive optical lens design A

Group Type EXPERIMENTAL

Virtual implantation

Intervention Type OTHER

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

Virtual implantation of diffractive optical lens design B

Group Type EXPERIMENTAL

Virtual implantation

Intervention Type OTHER

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

Virtual implantation of diffractive optical lens design C

Group Type EXPERIMENTAL

Virtual implantation

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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W Sickenberger, Prof

Role: PRINCIPAL_INVESTIGATOR

JenVis Research

Locations

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JenVis Research

Jena, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PJV2002

Identifier Type: -

Identifier Source: org_study_id