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 ]

near and distance visual acuity (Monoyer and Parinaud scales)


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