Study of Binocular Computer Activities for Treatment of Amblyopia

NCT02200211 | Completed Results DMC

• 2 other identifiers: ATS182U10EY011751
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play 7 days per week with 2 hours/day patching 7 days per week in children 5 to \<17

Conditions

Amblyopia

Keywords

Amblyopia

Outcome Measures

Primary Outcomes (6)

• Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years)

  Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children \<7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.

  Baseline and 16 weeks

• Mean Amblyopic Eye Visual Acuity (Younger Cohort)

  Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children \<7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA.

  16 Weeks from baseline

• Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)

  Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.

  Baseline and 16 weeks

• Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)

  Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.

  16 weeks

• Distribution of Change in Amblyopic-eye Visual Acuity

  Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children \<7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined). Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).

  Baseline and 16 weeks

• Distribution of Amblyopic-eye Visual Acuity

  Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children \<7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined). Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined).

  At 16 weeks

Secondary Outcomes (12)

• Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) From Baseline

  Baseline and 16-week visit

• Number of Participants With Resolution of Amblyopia

  16-week visit

• Time Course of Visual Acuity Improvement

  Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks

• Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups

  Baseline and 16 weeks

• Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups

  Baseline and 16 weeks

Other Outcomes (10)

• Percentage of Participants Reporting >75% of Prescribed Treatment Completed (Subjective Measures of Adherence)

  16 Weeks from baseline

• Participants Who Received Non-protocol, Alternative Treatment During the Study

  Entire study period, up to 16 weeks

• Safety Analysis: Distribution of the Change in Fellow-eye Visual Acuity From Baseline

  16-week visit

Study Arms (2)

Binocular Treatment

EXPERIMENTAL

Binocular computer game play 1 hour per day, 7 days per week (minimum of 4 days per week)

Device: iPad®

Patching Treatment

ACTIVE COMPARATOR

Patching 2 hours per day, 7 days per week

Other: Patching 2 hours per day, 7 days per week

Interventions

iPad® DEVICE

Binocular therapy on iPad®

Binocular Treatment

Patching 2 hours per day, 7 days per week OTHER

Also known as: Patching

Patching Treatment

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 5 to \<17 years
• Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
• Criteria for strabismus: At least one of the following must be met:
• Presence of a heterotropia on examination at distance or near fixation (with or without spectacles)
• Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
• Criteria for anisometropia: At least one of the following criteria must be met:
• ≥0.50 diopter (D) difference between eyes in spherical equivalent
• ≥1.50 D difference between eyes in astigmatism in any meridian
• Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
• Criteria for strabismus are met (see above)
• ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference between eyes in astigmatism in any meridian
• Note: the spherical equivalent requirement differs from that in the definition for refractive/anisometropic amblyopia
• No amblyopia treatment in the past 2 weeks (patching, atropine, Bangerter, vision therapy)
• Refractive correction (spectacles or contact lenses, if applicable) must meet the following criteria at enrollment and be based on a cycloplegic refraction that is not more than 7 months old.
• Requirements for Correction of Refractive Error:

You may not qualify if:

• A subject is excluded for any of the following reasons:
• Prism in the refractive correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
• Myopia greater than -6.00 D spherical equivalent in either eye.
• Previous intraocular or refractive surgery.
• Any treatment for amblyopia (patching, atropine, Bangerter filter, or vision therapy) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks immediately prior to enrollment.
• Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above visual acuity criteria are met).
• No Down syndrome or cerebral palsy
• No severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
• Heterotropia or heterophoria with a total ocular deviation \>10∆ (phoria plus tropia \>10∆) at near (measured by PACT).

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Pediatric Eye Disease Investigator Group: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Seattle Children's Hospital, University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• Holmes JM, Manh VM, Lazar EL, Beck RW, Birch EE, Kraker RT, Crouch ER, Erzurum SA, Khuddus N, Summers AI, Wallace DK; Pediatric Eye Disease Investigator Group. Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1391-1400. doi: 10.1001/jamaophthalmol.2016.4262.

  PMID: 27812703 RESULT

• Tailor V, Ludden S, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. Cochrane Database Syst Rev. 2022 Feb 7;2(2):CD011347. doi: 10.1002/14651858.CD011347.pub3.

  PMID: 35129211 DERIVED

Related Links

• PEDIG Public Website

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center
• Organization: Jaeb Center for Health Research

rkraker@jaeb.org

813-975-8690

Study Officials

• Jonathan Holmes, MD

  Mayo Clinic

  STUDY CHAIR

• Vivan Manh, OD

  University of Washington

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: September 11, 2014
• Primary Completion: August 19, 2016
• Study Completion: August 19, 2016
• Last Updated: February 27, 2019
• Results First Posted: October 15, 2018

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After primary manuscripts are published
• Access Criteria: Users accessing the data must enter an email address.

Locations

US (2)