Presbyopia Compensation: Looking for Electrophysiological Predictors

Presbyopia Clinical Trial

Official title:

Presbyopia Compensation: Looking for Electrophysiological Predictors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444130
• Other study ID #: 2013-A01677-38
• Status: Completed
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• normal acuity

Exclusion Criteria:

• stereoacuity disorder

• neurological disorders

Related Conditions & MeSH terms

• Presbyopia

Intervention

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

Locations

Country	Name	City	State
France	University hospital Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

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