Feasibility of a clinical trial of vision therapy for treatment of amblyopia

Don W. Lyon, Kristine Hopkins, Raymond H. Chu, Susanna M. Tamkins, Susan A. Cotter, B. Michele Melia, Jonathan M Holmes, Michael X. Repka, David T. Wheeler, Nicholas A. Sala, Janette Dumas, David I. Silbert

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)475-481
Number of pages7
JournalOptometry and Vision Science
Volume90
Issue number5
DOIs
StatePublished - May 2013

Fingerprint

Amblyopia
Clinical Trials
Therapeutics
Randomized Controlled Trials
Visual Acuity
Optometry
Depth Perception
Certification
Ophthalmology

Keywords

  • amblyopia
  • masking
  • patching
  • placebo vision therapy
  • vision therapy

ASJC Scopus subject areas

  • Ophthalmology
  • Optometry
  • Medicine(all)

Cite this

Lyon, D. W., Hopkins, K., Chu, R. H., Tamkins, S. M., Cotter, S. A., Melia, B. M., ... Silbert, D. I. (2013). Feasibility of a clinical trial of vision therapy for treatment of amblyopia. Optometry and Vision Science, 90(5), 475-481. https://doi.org/10.1097/OPX.0b013e31828def04

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.

In: Optometry and Vision Science, Vol. 90, No. 5, 05.2013, p. 475-481.

Research output: Contribution to journalArticle

Lyon, DW, Hopkins, K, Chu, RH, Tamkins, SM, Cotter, SA, Melia, BM, Holmes, JM, Repka, MX, Wheeler, DT, Sala, NA, Dumas, J & Silbert, DI 2013, 'Feasibility of a clinical trial of vision therapy for treatment of amblyopia', Optometry and Vision Science, vol. 90, no. 5, pp. 475-481. https://doi.org/10.1097/OPX.0b013e31828def04
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. / Feasibility of a clinical trial of vision therapy for treatment of amblyopia. In: Optometry and Vision Science. 2013 ; Vol. 90, No. 5. pp. 475-481.
@article{b7851a7377c548b1add771465953df05,
title = "Feasibility of a clinical trial of vision therapy for treatment of amblyopia",
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.",
keywords = "amblyopia, masking, patching, placebo vision therapy, vision therapy",
author = "Lyon, {Don W.} and Kristine Hopkins and Chu, {Raymond H.} and Tamkins, {Susanna M.} and Cotter, {Susan A.} and Melia, {B. Michele} and Holmes, {Jonathan M} and Repka, {Michael X.} and Wheeler, {David T.} and Sala, {Nicholas A.} and Janette Dumas and Silbert, {David I.}",
year = "2013",
month = "5",
doi = "10.1097/OPX.0b013e31828def04",
language = "English (US)",
volume = "90",
pages = "475--481",
journal = "Optometry and Vision Science",
issn = "1040-5488",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - Feasibility of a clinical trial of vision therapy for treatment of amblyopia

AU - Lyon, Don W.

AU - Hopkins, Kristine

AU - Chu, Raymond H.

AU - Tamkins, Susanna M.

AU - Cotter, Susan A.

AU - Melia, B. Michele

AU - Holmes, Jonathan M

AU - Repka, Michael X.

AU - Wheeler, David T.

AU - Sala, Nicholas A.

AU - Dumas, Janette

AU - Silbert, David I.

PY - 2013/5

Y1 - 2013/5

N2 - 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.

AB - 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.

KW - amblyopia

KW - masking

KW - patching

KW - placebo vision therapy

KW - vision therapy

UR - http://www.scopus.com/inward/record.url?scp=84876838216&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84876838216&partnerID=8YFLogxK

U2 - 10.1097/OPX.0b013e31828def04

DO - 10.1097/OPX.0b013e31828def04

M3 - Article

C2 - 23563444

AN - SCOPUS:84876838216

VL - 90

SP - 475

EP - 481

JO - Optometry and Vision Science

JF - Optometry and Vision Science

SN - 1040-5488

IS - 5

ER -