Presbyopia Compensation: Looking for Electrophysiological Predictors

Presbyopia Compensation: Looking for Electrophysiological Predictors

Sponsors

Lead Sponsor: University Hospital, Tours

Source 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).

Overall Status Unknown status
Start Date 2015-02-01
Completion Date 2016-02-01
Primary Completion Date 2015-05-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Visual acuity at baseline baseline
Secondary Outcome
Measure Time Frame
electrophysiological recordings at baseline baseline
electrophysiological recordings change with monovision after 3 weeks with monovision contact lenses
electrophysiological recordings with multifocality after 3 weeks with multifocality contact lenses
quantitative measurement of stereopsis at baseline baseline
quantitative measurement of stereopsis with monovision after 3 weeks with monovision contact lenses
quantitative measurement of stereopsis with multifocality after 3 weeks with multifocality contact lenses
Visual acuity change with monovision after 3 weeks with monovision contact lenses
Visual acuity change with multifocality after 3 weeks with multifocality contact lenses
Enrollment 40
Condition
Intervention

Intervention Type: Device

Intervention Name: contact lenses

Description: Presbyopia was compensated with contact lenses by monovision and multifocality.

Eligibility

Sampling Method:

Probability Sample

Criteria:

Inclusion Criteria: - normal acuity Exclusion Criteria: - stereoacuity disorder - neurological disorders

Gender:

All

Minimum Age:

45 Years

Maximum Age:

60 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Pierre-Jean Pisella, MD, PhD Principal Investigator University Hospital, Tours
Overall Contact

Last Name: Magali Batty, PhD

Phone: +33 2 47 47 84 12

Email: [email protected]

Location
Facility: Status: University hospital Tours
Location Countries

France

Verification Date

2015-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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