Presbyopia Compensation: Looking for Electrophysiological Predictors

November 2, 2022 updated by: University Hospital, Tours
The main purpose of this study was to identify electrophysiological predictive markers of post-correction visual comfort for presbyopic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37000
        • university hospital Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with presbyopia

Description

Inclusion Criteria:

  • normal acuity

Exclusion Criteria:

  • stereoacuity disorder
  • neurological disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity at baseline
Time Frame: baseline
near and distance visual acuity (Monoyer and Parinaud scales)
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
electrophysiological recordings at baseline
Time Frame: baseline
monocular and binocular pattern Visual Evoked Potentials in response to a checkerboard pattern N75 and P100 components : amplitude, latency and topography
baseline
electrophysiological recordings change with monovision
Time Frame: after 3 weeks with monovision contact lenses
monocular and binocular pattern Visual Evoked Potentials in response to a checkerboard pattern N75 and P100 components : amplitude, latency and topography
after 3 weeks with monovision contact lenses
electrophysiological recordings with multifocality
Time Frame: after 3 weeks with multifocality contact lenses
monocular and binocular pattern Visual Evoked Potentials in response to a checkerboard pattern N75 and P100 components : amplitude, latency and topography
after 3 weeks with multifocality contact lenses
quantitative measurement of stereopsis at baseline
Time Frame: baseline
TNO plates
baseline
quantitative measurement of stereopsis with monovision
Time Frame: after 3 weeks with monovision contact lenses
TNO plates
after 3 weeks with monovision contact lenses
quantitative measurement of stereopsis with multifocality
Time Frame: after 3 weeks with multifocality contact lenses
TNO plates
after 3 weeks with multifocality contact lenses
Visual acuity change with monovision
Time Frame: after 3 weeks with monovision contact lenses
near and distance visual acuity (Monoyer and Parinaud scales)
after 3 weeks with monovision contact lenses
Visual acuity change with multifocality
Time Frame: after 3 weeks with multifocality contact lenses
near and distance visual acuity (Monoyer and Parinaud scales)
after 3 weeks with multifocality contact lenses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Pierre-Jean Pisella, MD, PhD, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01677-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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