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

NCT00587171 | Terminated Phase 3 Results DMC

• 2 other identifiers: NEI-1382U10EY011751
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Amblyopia

Keywords

Amblyopia; Vision Therapy; Patching

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Distribution of Fellow Eye Visual Acuity at 17 Weeks

  17 weeks

• Mean (SD) of Fellow Eye Visual Acuity at 17 Weeks

  17 weeks

• Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks

  Baseline to 17 weeks

• Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks

  Baseline to 17 weeks

• Mean (SD) of Intereye Visual Acuity at 17 Weeks

  17 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

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; Procedure: Near activities; Procedure: Active vision therapy

Control

SHAM COMPARATOR

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; Procedure: Near activities; Procedure: Control vision therapy

Interventions

Patching DEVICE

2 hours daily patching

Also known as: Coverlet, 3M Opticlude, Ortopad®

Active; Control

Near activities PROCEDURE

30 minutes daily near activities at home

Active; Control

Active vision therapy PROCEDURE

30 minutes of daily at-home active vision therapy and a weekly 45 minute in-office active vision therapy session

Active

Control vision therapy PROCEDURE

30 minutes of daily at-home control vision therapy and a weekly 45 minute in-office control vision therapy session

Control

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator

Study Sites (7)

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama, 35294, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Indiana University School of Optometry

Bloomington, Indiana, 47405, United States

Location

Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, 16501, United States

Location

Family Eye Group

Lancaster, Pennsylvania, 17601, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Related Publications (1)

• 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.

  PMID: 23563444 RESULT

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

Limitations and Caveats

The study was stopped prior to achieving the goal of 45 subjects enrolled due to slow recruitment, leaving only 19 subjects enrolled.

Results Point of Contact

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

pedig@jaeb.org

813-975-8690

Study Officials

• Don W. Lyon, O.D.

  Indiana University

  STUDY CHAIR

• David T. Wheeler, M.D.

  Casey Eye Institute

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, PEDIG Coordinating Center

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: January 7, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 13, 2016
• Results First Posted: May 18, 2011

Record last verified: 2016-07

Locations

US (7)