NCT02180347

Brief Summary

The objective of this study is to determine if multifocal contact lenses affect accommodation and/or binocular vision when worn by pediatric patients. This will be accomplished through subjective and objective accommodative and binocular experiments in children wearing single vision and multifocal soft contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

June 30, 2014

Last Update Submit

July 8, 2016

Conditions

Myopia

Keywords

PediatricsContact lenses

Outcome Measures

Primary Outcomes (2)

  • Accommodative response

    Accommodative response will be measured subjectively and objectively using the push-up technique and photorefraction.

    Up to two hours

  • Binocular posture status

    Binocular posture will be measured using Modified Thorington,

    Up to two hours

Study Arms (2)

Multifocal contact lenses

Coopervision Proclear Multifocal

Device: Contact lenses

Single vision contact lenses

Coopervision Proclear Sphere

Device: Contact lenses

Interventions

Contact lensesDEVICE
Multifocal contact lensesSingle vision contact lenses

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population includes children and teens that are recruited from the University Eye Center at SUNY College of Optometry and from the greater New York City area.

You may qualify if:

  • to 15 years of age
  • Refractive error between -1.00 and -8.00 D sphere, with less than or equal to 1.00 D astigmatism
  • Corrected visual acuity of 20/25 or better in each eye

You may not qualify if:

  • Ocular or systemic disease known to affect accommodation or vision
  • Convergence or accommodative disorder, or any strabismus
  • Use of oral or topical medications known to affect accommodation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY College of Optometry, Clinical Vision Research Center

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Kathryn Richdale, OD, PhD

    State University of New York College of Optometry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 2, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

US(1)