Presbyopia Compensation: Looking for Electrophysiological Predictors

Completed

• Conditions: Presbyopia

• Registration Number: NCT02444130
• Lead Sponsor: University Hospital, Tours

Brief Summary

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

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-18
• Primary Completion: 2015-05
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Study Completion: 2016-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• normal acuity

Exclusion Criteria

• stereoacuity disorder
• neurological disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity at baseline	baseline	near and distance visual acuity (Monoyer and Parinaud scales)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University hospital Tours; 🇫🇷 Tours, France