Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia (ATS12)

A Randomized Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia in Children 7 to <13 Years Old

This study is comparing the effectiveness of patching combined with active vision therapy plus near activities versus patching combined with control vision therapy plus near activities for moderate amblyopia (20/40-20/100) in 7 to <13 year olds.

The primary outcome measure is the proportion of patients with visual acuity of 20/25 or better in the amblyopic eye at the 17-week masked exam. These patients will be considered treatment responders. The primary analysis will consist of a comparison between the 2 treatment groups of the proportion of treatment responders with adjustment for baseline visual acuity.

Secondary outcomes are stereoacuity at the 17-week masked exam, mean improvement in visual acuity at the 17-week masked exam, and rate of improvement of visual acuity.

Study Overview

• Status: Terminated
• Conditions: Amblyopia
• Intervention / Treatment: Device: Patching; Procedure: Near activities; Procedure: Active vision therapy; Procedure: Control vision therapy

Detailed Description

Patching and atropine have been traditionally used for the improvement of visual acuity in children with amblyopia. Previous studies have shown that these methods of treatment are effective in young children with functional amblyopia. More recently ATS3, a randomized clinical trial of 507 children ages 7-<18, found that part-time patching combined with atropine and near activities improved visual acuity by two or more lines in 53% of the 7 to 12 year olds compared to 25% for optical correction alone. For the 13 to 17 year olds, part-time patching and near activities improved visual acuity by 2 or more lines in 25%, compared to 23% for optical correction alone. While it appears that patching and/or atropine, combined with near activities, can improve visual acuity in some patients ages 7-<18, most patients in the study were left with residual visual acuity deficits. To further improve visual acuity and binocularity in children with amblyopia some eye care providers augment these traditional therapies with vision therapy. Vision therapy is prescribed initially if there is moderate amblyopia with stereopsis. Vision therapy can be added to the treatment regimen once the patient has reached moderate levels of vision loss with stereopsis and if the patient is still not responding to the current treatment and still has moderate amblyopia. It is thought that the best candidates for this type of therapy are those children with a minimum level of stereopsis (at least 800") and without constant strabismus. Those children with no stereopsis would not be able to perform the activities in the later stages of therapy utilizing binocular vision.

Vision therapy is a sequence of prescribed activities typically performed on a daily basis at home and weekly in-office, and is directed toward an individual patient's deficient skills. Visual skills are practiced under conditions that provide the patient with feedback. The feedback, along with a gradual increase in the demand of the activities as improvement occurs, enables the patient to improve visual functions such as visual acuity, fixation, accommodation, and vergence skills.

There have been case reports and small sample studies that have shown that vision therapy in combination with spectacles and occlusion is effective in improving the visual acuity of patients with amblyopia. Wick et al looked at nineteen patients who were diagnosed with anisometropic amblyopia between the ages of 6 to 49. Seventeen of the patients had moderate amblyopia and two had severe amblyopia, based on the definition of amblyopia used in the Amblyopia Treatment Studies. The patients were treated with a sequence that included spectacle correction, occlusion therapy and both monocular and binocular vision therapy. Thirteen of the seventeen patients with moderate amblyopia had a final visual acuity of 20/25 or better and all of the patients with moderate amblyopia had 20/30 or better final visual acuity.

More recent reports on "perceptual learning," an active form of therapy in which amblyopic subjects practice a position-discrimination task, have shown a mean acuity improvement of approximately 30% (two lines) in amblyopic children and adults who had completed occlusion therapy. These studies provide support for the notion that the practice of particular visual skills under conditions that provide the patient with feedback (e.g., vision therapy) may be beneficial in improving the visual performance of amblyopic eyes.

The second reason to prescribe active therapy is to enhance or facilitate the effects of occlusion by directly treating the aforementioned deficits found to be associated with amblyopia. Most therapy procedures are designed to remediate specific deficiencies in four main areas: fixation, spatial perception, accommodative efficiency, binocular function and oculomotor control.

Lastly, some investigators have suggested that the use of vision therapy may reduce the likelihood of recurrence of the amblyopia. This may be particularly true with anisometropic amblyopia in which vision therapy can be used to improve binocular function.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Pediatric Eye Care; Birmingham Health Care
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University School of Optometry
  • Oregon
    • Portland, Oregon, United States, 97239
      • Casey Eye Institute
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16501
      • Pediatric Ophthalmology of Erie
    • Lancaster, Pennsylvania, United States, 17601
      • Family Eye Group
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Southern College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 7 to <13 years
• Amblyopia associated with anisometropia, strabismus (comitant or incomitant), or both at the time of the eligibility examination
• Visual acuity in the amblyopic eye between 49 and 71 letters inclusive (20/40 to 20/100 inclusive) on the eETDRS
• Visual acuity in the sound eye of 79 or more letters on the eETDRS (20/25 or better)
• Inter-eye acuity difference of 15 or more letters (3 or more logMAR lines)
• At least 800 seconds of arc on the Randot Preschool Stereoacuity Test
• Previous or current amblyopia treatment with spectacles or contact lenses, patching or atropine is permitted.
• No myopia more than -6.00 D spherical equivalent in the amblyopic eye
• Single vision spectacles, if needed, worn for at least 16 weeks or until visual acuity documented to be stable
• The child has access to a computer on a daily basis (to use the home vision therapy software)

Exclusion Criteria:

• Previous vision therapy or orthoptics
• Known skin reactions to patch or bandage adhesives
• Prior intraocular or refractive surgery
• Bifocals
• Constant strabismus at near at the eligibility examination
• A family member is (or has been) enrolled in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy	Device: Patching; 2 hours daily patching; Other Names: Coverlet, 3M Opticlude, Ortopad®; Procedure: Near activities; 30 minutes daily near activities at home; Procedure: Active vision therapy; 30 minutes of daily at-home active vision therapy and a weekly 45 minute in-office active vision therapy session
Sham Comparator: Control; 2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy	Device: Patching; 2 hours daily patching; Other Names: Coverlet, 3M Opticlude, Ortopad®; Procedure: Near activities; 30 minutes daily near activities at home; Procedure: Control vision therapy; 30 minutes of daily at-home control vision therapy and a weekly 45 minute in-office control vision therapy session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.	17 weeks
Mean (SD): Distance Visual Acuity in Amblyopic Eye at 17-week Outcome	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.	17 weeks
Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	Baseline to 17 weeks
Mean (SD) of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	Baseline to 17 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Fellow Eye Visual Acuity at 17 Weeks	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.	17 weeks
Mean (SD) of Fellow Eye Visual Acuity at 17 Weeks	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.	17 weeks
Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	Baseline to 17 weeks
Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	Baseline to 17 weeks
Mean (SD) of Intereye Visual Acuity at 17 Weeks	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.	17 weeks
Mean (SD) of Change in Intereye Visual Acuity From Baseline to 17 Weeks	Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	Baseline to 17 weeks
Distribution of Randot Preschool Stereoacuity at 17 Weeks	The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.	17 weeks
Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks	The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.	Baseline to 17 weeks

Collaborators and Investigators

• Sponsor: Jaeb Center for Health Research
• Collaborators: National Eye Institute (NEI)
• Investigators: Study Chair: Don W. Lyon, O.D., Indiana University School of Optometry; Study Chair: David T. Wheeler, M.D., Casey Eye Institute

Publications and helpful links

General Publications

• Lyon DW, Hopkins K, Chu RH, Tamkins SM, Cotter SA, Melia BM, Holmes JM, Repka MX, Wheeler DT, Sala NA, Dumas J, Silbert DI; Pediatric Eye Disease Investigator Group. Feasibility of a clinical trial of vision therapy for treatment of amblyopia. Optom Vis Sci. 2013 May;90(5):475-81. doi: 10.1097/OPX.0b013e31828def04.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: December 10, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 7, 2008

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 7, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Amblyopia; Vision Therapy; Patching
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: NEI-138; 2U10EY011751 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No