Feasibility of a Clinical Trial of Vision Therapy for Treatment of Amblyopia : Optometry and Vision Science

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Feasibility of a Clinical Trial of Vision Therapy for Treatment of Amblyopia

Lyon, Don W.*; Hopkins, Kristine†; Chu, Raymond H.*; Tamkins, Susanna M.‡; Cotter, Susan A.§; Melia, B. Michele∥; Holmes, Jonathan M.**; Repka, Michael X.††; Wheeler, David T.‡‡; Sala, Nicholas A.§§; Dumas, Janette∥∥; Silbert, David I.‡‡ on behalf of the Pediatric Eye Disease Investigator Group

Author Information

*OD, MS, FAAO

†OD, MSPH, FAAO

‡OD, FAAO

§OD, MS

∥ScM

**BM, BCh

††MD, MBA

‡‡MD

§§DO

∥∥OD

Indiana University School of Optometry, Bloomington, Indiana (DWL); School of Optometry, University of Alabama at Birmingham, Birmingham, Alabama (KH); Southern California College of Optometry, Fullerton, California (RHC, SAC); Bascom Palmer Eye Institute, Miami, Florida (SMT); Jaeb Center for Health Research, Tampa, Florida (MM); Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota (JMH); Johns Hopkins University School of Medicine, Baltimore, Maryland (MXR); Casey Eye Institute, Portland, Oregon (DTW); Pediatric Ophthalmology of Erie, Erie, Pennsylvania (NAS); Southern College of Optometry, Memphis, Tennessee (JD); and Family Eye Group, Lancaster, Pennsylvania (DIS).

Don W. Lyon c/o Jaeb Center for Health Research 15310 Amberly Dr Suite 350 Tampa, FL 33647 e-mail: [email protected]

Optometry and Vision Science 90(5):p 475-481, May 2013. | DOI: 10.1097/OPX.0b013e31828def04

Abstract

Purpose 

We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial.

Methods 

A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40–20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy.

Results 

Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures.

Conclusions 

This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.

© 2013 American Academy of Optometry

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