Presbyopia Compensation: Looking for Electrophysiological Predictors

• Sponsor: University Hospital, Tours (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02444130
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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	Phase
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).

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Presbyopia Compensation: Looking for Electrophysiological Predictors
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: May 1, 2015
• Anticipated Study Completion Date: Feb 1, 2016

Outcome Measures

Primary Outcome Measures

1. Visual acuity at baseline [baseline]

   near and distance visual acuity (Monoyer and Parinaud scales)

Secondary Outcome Measures

1. electrophysiological recordings at baseline [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 [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 [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 [baseline]

   TNO plates

5. quantitative measurement of stereopsis with monovision [after 3 weeks with monovision contact lenses]

   TNO plates

6. quantitative measurement of stereopsis with multifocality [after 3 weeks with multifocality contact lenses]

   TNO plates

7. Visual acuity change with monovision [after 3 weeks with monovision contact lenses]

   near and distance visual acuity (Monoyer and Parinaud scales)

8. Visual acuity change with multifocality [after 3 weeks with multifocality contact lenses]

   near and distance visual acuity (Monoyer and Parinaud scales)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• normal acuity

Exclusion Criteria:

• stereoacuity disorder

• neurological disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital Tours	Tours		France	37000

Sponsors and Collaborators

• University Hospital, Tours

Investigators

• Principal Investigator: Pierre-Jean Pisella, MD, PhD, University Hospital, Tours

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Tours
• ClinicalTrials.gov Identifier: NCT02444130
• Other Study ID Numbers: 2013-A01677-38
• First Posted: May 14, 2015
• Last Update Posted: Jul 20, 2015
• Last Verified: May 1, 2015

• Keywords provided by University Hospital, Tours: multifocality; monovision
• Additional relevant MeSH terms: Presbyopia

Study Results

No Results Posted as of Jul 20, 2015