NCT02444130

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

February 18, 2015

Last Update Submit

November 2, 2022

Conditions

Presbyopia

Keywords

multifocalitymonovision

Outcome Measures

Primary Outcomes (1)

  • Visual acuity at baseline

    near and distance visual acuity (Monoyer and Parinaud scales)

    baseline

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

contact lensesDEVICE

Presbyopia was compensated with contact lenses by monovision and multifocality.

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adults with presbyopia

You may qualify if:

  • normal acuity

You may not qualify if:

  • stereoacuity disorder
  • neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Tours

Tours, 37000, France

Location

Related Publications (1)

  • Imbeau L, Majzoub S, Thillay A, Bonnet-Brilhault F, Pisella PJ, Batty M. Presbyopia compensation: looking for cortical predictors. Br J Ophthalmol. 2017 Feb;101(2):223-226. doi: 10.1136/bjophthalmol-2015-307581. Epub 2016 Apr 22.

    PMID: 27107029DERIVED

MeSH Terms

Conditions

Presbyopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Pierre-Jean Pisella, MD, PhD

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2015

First Posted

May 14, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2015

Study Completion

February 1, 2016

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

FR(1)