Presbyopia Compensation: Looking for Electrophysiological Predictors

NCT ID: NCT02444130

Last Updated: 2022-11-03

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

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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The main purpose of this study was to identify electrophysiological predictive markers of post-correction visual comfort for presbyopic patients.

Detailed Description

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For each participant, presbyopia was compensated with contact lenses by monovision during three weeks and multifocality (three weeks again). A break of two weeks without any presbyopia compensation came in between the two phases of the test that were randomized.

All subjects were tested three times: before any compensation, after three weeks with monovsion and after three weeks with multifocality.

Each testing session was strictly the same including visual examinations and VEPs (visual evoked potentials).

Conditions

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Presbyopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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contact lenses

Presbyopia was compensated with contact lenses by monovision and multifocality.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* normal acuity

Exclusion Criteria

* stereoacuity disorder
* neurological disorders
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Jean Pisella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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University hospital Tours

Tours, , France

Site Status

Countries

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France

References

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Imbeau L, Majzoub S, Thillay A, Bonnet-Brilhault F, Pisella PJ, Batty M. Presbyopia compensation: looking for cortical predictors. Br J Ophthalmol. 2017 Feb;101(2):223-226. doi: 10.1136/bjophthalmol-2015-307581. Epub 2016 Apr 22.

Reference Type DERIVED
PMID: 27107029 (View on PubMed)

Other Identifiers

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2013-A01677-38

Identifier Type: -

Identifier Source: org_study_id

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