Contact Lenses and Myopia (CLAM)

July 8, 2016 updated by: Kathryn Richdale, State University of New York College of Optometry
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10036
        • SUNY College of Optometry, Clinical Vision Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 7 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multifocal contact lenses
Coopervision Proclear Multifocal
Device: Contact lenses
Single vision contact lenses
Coopervision Proclear Sphere
Device: Contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accommodative response
Time Frame: Up to two hours
Accommodative response will be measured subjectively and objectively using the push-up technique and photorefraction.
Up to two hours
Binocular posture status
Time Frame: Up to two hours
Binocular posture will be measured using Modified Thorington,
Up to two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York College of Optometry

Investigators

  • Principal Investigator: Kathryn Richdale, OD, PhD, State University of New York College of Optometry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAM_602929 (Other Identifier: SUNY College of Optometry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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