Contact Lenses and Myopia

Myopia Clinical Trial

— CLAM  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180347
• Other study ID #: CLAM_602929
• Secondary ID: CLAM_602929
• Status: Completed
• Phase: N/A
• First received: June 30, 2014
• Last updated: July 8, 2016
• Start date: June 2014
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: State University of New York College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Local Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Contact lenses

Locations

Country	Name	City	State
United States	SUNY College of Optometry, Clinical Vision Research Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York College of Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accommodative response	Accommodative response will be measured subjectively and objectively using the push-up technique and photorefraction.	Up to two hours	No
Primary	Binocular posture status	Binocular posture will be measured using Modified Thorington,	Up to two hours	No

External Links

•   CVRC contact lens research website