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Completed

NCT Number: NCT02444130

Presbyopia Compensation: Looking for Electrophysiological Predictors

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

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital Tours

Tours, 37000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • normal acuity

Exclusion criteria

  • stereoacuity disorder
  • neurological disorders

Treatment and study plan

Contact Lenses

Device

Presbyopia was compensated with contact lenses by monovision and multifocality.

Primary outcomes

  1. Visual acuity at baseline

    Time frame: baseline

    near and distance visual acuity (Monoyer and Parinaud scales)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. quantitative measurement of stereopsis at baseline

    Time frame: baseline

    TNO plates

  5. quantitative measurement of stereopsis with monovision

    Time frame: after 3 weeks with monovision contact lenses

    TNO plates

  6. quantitative measurement of stereopsis with multifocality

    Time frame: after 3 weeks with multifocality contact lenses

    TNO plates

  7. Visual acuity change with monovision

    Time frame: after 3 weeks with monovision contact lenses

    near and distance visual acuity (Monoyer and Parinaud scales)

  8. Visual acuity change with multifocality

    Time frame: after 3 weeks with multifocality contact lenses

    near and distance visual acuity (Monoyer and Parinaud scales)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 14, 2015
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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