Clinical Trial: Presbyopia Compensation: Looking for Electrophysiological Predictors
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational [Patient Registry]
Official Title: Presbyopia Compensation: Looking for Electrophysiological Predictors
Brief Summary: The main purpose of this study was to identify electrophysiological predictive markers of post-correction visual comfort for presbyopic patients.
Detailed Summary:
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).
Sponsor: University Hospital, Tours
Current Primary Outcome: Visual acuity at baseline [ Time Frame: baseline ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
- 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
- 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
- quantitative measurement of stereopsis at baseline [ Time Frame: baseline ]TNO plates
- quantitative measurement of stereopsis with monovision [ Time Frame: after 3 weeks with monovision contact lenses ]TNO plates
- quantitative measurement of stereopsis with multifocality [ Time Frame: after 3 weeks with multifocality contact lenses ]TNO plates
- Visual acuity change with monovision [ Time Frame: after 3 weeks with monovision contact lenses ]near and distance visual acuity (Monoyer and Parinaud scales)
- Visual acuity change with multifocality [ Time Frame: after 3 weeks with multifocality contact lenses ]near and distance visual acuity (Monoyer and Parinaud scales)
Original Secondary Outcome: Same as current
Information By: University Hospital, Tours
Dates:
Date Received: February 18, 2015
Date Started: February 2015
Date Completion: February 2016
Last Updated: July 17, 2015
Last Verified: May 2015