Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children

NCT00525174 | Completed Phase 3 Results DMC

• 2 other identifiers: NEI-1362U10EY011751
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized clinical trial designed to evaluate the non-inferiority of Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate amblyopia (20/40 to 20/80) in children ages 3 to \< 10 years. Secondary objectives of this study are (1) to determine the time course of visual improvement with Bangerter filter treatment, (2) to compare patient quality of life, measured by a modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter filters, (3) to determine whether blurring the sound eye to a visual acuity worse than the amblyopic eye predicts improvement in acuity, and (4) to determine whether a change in fixation to the amblyopic eye is predictive of improvement in visual acuity. The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound eyes. The primary analytic approach for the amblyopic eye acuity will involve construction of a one-sided 95% confidence interval to assess non-inferiority based on a treatment group comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an analysis of covariance (ANCOVA) model. Sound eye acuity data will be reported for each treatment regimen at the 24-week visit as mean change (logMAR lines) from baseline and as the distribution of the number of lines of change from baseline.

Conditions

Amblyopia

Keywords

Amblyopia; Patching; Bangerter filters

Outcome Measures

Primary Outcomes (4)

• Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks

  Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to \<7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).

  24 weeks

• Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks

  Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to \<7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).

  24 weeks

• Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks

  Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). 'Worse' indicates acuity at 24 weeks is worse than acuity at baseline; 'Better' indicates acuity at 24 weeks is better than acuity at baseline.

  Baseline to 24 weeks

• Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks

  Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to \<7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).

  Baseline to 24 weeks

Secondary Outcomes (18)

• Mean Interocular Difference at 24 Weeks

  24 weeks

• Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks

  24 weeks

• Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks

  24 weeks

• Distribution of Subjects With 3 or More Lines of Improvement

  Baseline to 24 weeks

• Distribution of Patient Characteristics at the 24-week Outcome Exam.

  24 weeks

Study Arms (2)

Patching

ACTIVE COMPARATOR

2 hours daily patching of the sound eye plus one hour near activities while patching

Device: Patching; Procedure: Near activities

Bangerter filters

ACTIVE COMPARATOR

Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities

Device: Bangerter filters; Procedure: Near activities

Interventions

Bangerter filters DEVICE

Bangerter filter worn on sound eye spectacle lens full time

Bangerter filters

Patching DEVICE

2 hours daily patching of the sound eye

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

Patching

Near activities PROCEDURE

one hour near visual activities

Bangerter filters; Patching

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3 to \< 10 years
• Amblyopia associated with strabismus, anisometropia, or both
• No ocular cause apparent for reduced visual acuity
• Visual acuity 20/40 to 20/80 (71 to 54 letters inclusive) in amblyopic eye
• Visual acuity 20/40 or better (\>= 69 letters) in sound eye
• Interocular difference \>= 3 logMAR lines (\>= 15 letters)
• No amblyopia treatment other than spectacles in last 6 months
• \*Any treatment more than 6 months prior to enrollment is acceptable
• Currently wearing spectacles
• Appropriate spectacles have been worn for 16 weeks prior to enrollment or visual acuity documented to be stable
• No myopia \> -6.00 D spherical equivalent in either eye
• Cycloplegic refraction within 6 months prior to enrollment
• Ocular examination within 6 months prior to enrollment

You may not qualify if:

• Current vision therapy or orthoptics
• Ocular cause for reduced visual acuity
• Prior intraocular or refractive surgery
• Known skin reactions to patch or bandage adhesives

Sponsors & Collaborators

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

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

• Pediatric Eye Disease Investigator Group Writing Committee; Rutstein RP, Quinn GE, Lazar EL, Beck RW, Bonsall DJ, Cotter SA, Crouch ER, Holmes JM, Hoover DL, Leske DA, Lorenzana IJ, Repka MX, Suh DW. A randomized trial comparing Bangerter filters and patching for the treatment of moderate amblyopia in children. Ophthalmology. 2010 May;117(5):998-1004.e6. doi: 10.1016/j.ophtha.2009.10.014. Epub 2010 Feb 16.

  PMID: 20163869 RESULT

• Rutstein RP, Foster NC, Cotter SA, Kraker RT, Lee DH, Melia M, Quinn GE, Tamkins SM, Wallace DK; Pediatric Eye Disease Investigator Group. Visual acuity through Bangerter filters in nonamblyopic eyes. J AAPOS. 2011 Apr;15(2):131-4. doi: 10.1016/j.jaapos.2010.11.015. Epub 2011 Mar 21.

  PMID: 21419678 RESULT

• Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.

  PMID: 22108357 DERIVED

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

Compliance assessment was based on parents' diaries and judgment by the researchers. Because we did not use an objective method to measure occlusion or spectacle wear, we cannot guarantee that the patients adhered to their prescribed regimens.

Results Point of Contact

• Title: Raymond Kraker, MSPH
• Organization: Jaeb Center for Health Research

pedig@jaeb.org

813-875-8690

Study Officials

• Robert P. Rutstein, O.D., M.S.

  University of Alabama at Birmingham

  STUDY CHAIR

• Graham E. Quinn, M.D., MSCE

  Children's Hospital of Philadelphia

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, PEDIG Coordinating Center

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 5, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 13, 2016
• Results First Posted: June 17, 2011

Record last verified: 2016-07

Locations

US (1)