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Presbyopia Compensation: Looking for Electrophysiological Predictors

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ClinicalTrials.gov Identifier: NCT02444130
Recruitment Status : Unknown
Verified May 2015 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : May 14, 2015
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Presbyopia Device: contact lenses

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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Weeks
Official Title: Presbyopia Compensation: Looking for Electrophysiological Predictors
Study Start Date : February 2015
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : February 2016

Intervention Details:
  • Device: contact lenses
    Presbyopia was compensated with contact lenses by monovision and multifocality.


Primary Outcome Measures :
  1. Visual acuity at baseline [ Time Frame: baseline ]
    near and distance visual acuity (Monoyer and Parinaud scales)


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with presbyopia
Criteria

Inclusion Criteria:

  • normal acuity

Exclusion Criteria:

  • stereoacuity disorder
  • neurological disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444130


Contacts
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Contact: Magali Batty, PhD +33 2 47 47 84 12 magali.batty@univ-tours.fr

Locations
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France
University hospital Tours Recruiting
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Pierre-Jean Pisella, MD, PhD University Hospital, Tours
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02444130    
Other Study ID Numbers: 2013-A01677-38
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: May 2015
Keywords provided by University Hospital, Tours:
multifocality
monovision
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases