Increasing Patching for Amblyopia in Children 3 to < 8 Years Old

NCT00945100 | Completed Phase 3 Results DMC

• 2 other identifiers: NEI-1432U10EY011751
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. Children ages 3 to \<8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week). The primary objective is to determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

Conditions

Amblyopia

Keywords

Amblyopia; patching; occlusion

Outcome Measures

Primary Outcomes (4)

• Distribution of 10-week Amblyopic Eye Visual Acuity

  The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.

  10 weeks after randomization

• Mean 10-week Amblyopic Eye Visual Acuity

  The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.

  10 weeks after randomization

• Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization

  The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.

  Randomization to 10 weeks

• Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization

  The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.

  Randomization to 10 weeks

Secondary Outcomes (26)

• Compliance With Prescribed Patching by Treatment Group at 10 Weeks

  10 weeks after randomization

• Average Compliance With Prescribed Patching by Treatment Group

  10 weeks after randomization or later

• Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization

  10 weeks after randomization

• Treatment Group Comparison of 10-week Interocular Difference

  10 weeks after randomization

• Distribution of Baseline Characteristics at the 10-week Outcome

  10 weeks after randomization

Study Arms (2)

Control

ACTIVE COMPARATOR

2 hours daily patching

Device: Eye Patch

Intensified treatment

ACTIVE COMPARATOR

42 hours per week of patching (averaging 6 hours daily)

Device: Eye Patch

Interventions

Eye Patch DEVICE

42 hours patching per week (averaging 6 hours patching daily)

Also known as: Coverlet, 3M Opticlude, Ortopad

Intensified treatment

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Major Eligibility Criteria for Run-in Phase
• Age 3 to \< 8 years
• Amblyopia associated with strabismus, anisometropia, or both
• Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
• Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference \>3 logMAR lines
• Amblyopia treatment within the past 6 months subject to the following stipulations:
• No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with 2 hours of patching per day who are entering the study on treatment)
• No simultaneous treatment with patching and atropine
• No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
• Maximum level of treatment within the past 6 months:
• Patching: up to 2 hours daily
• Atropine: up to once daily
• Wearing spectacles with optimal correction (if applicable); if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses. If amblyopic eye acuity is 20/100 or worse, then spectacles and patching can be initiated simultaneously.
• Eligibility Criteria for Randomization:
• Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of \>2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.

You may not qualify if:

• Currently using vision therapy or orthoptics
• Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
• Prior intraocular or refractive surgery
• Known skin reaction to patch or bandage adhesives

Sponsors & Collaborators

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

Study Sites (2)

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• Wallace DK, Lazar EL, Crouch ER 3rd, Hoover DL, Kraker RT, Tamkins SM; Pediatric Eye Disease Investigator Group. Time course and predictors of amblyopia improvement with 2 hours of daily patching. JAMA Ophthalmol. 2015 May;133(5):606-9. doi: 10.1001/jamaophthalmol.2015.6. No abstract available.

  PMID: 25695355 BACKGROUND

• Pediatric Eye Disease Investigator Group; Wallace DK, Lazar EL, Holmes JM, Repka MX, Cotter SA, Chen AM, Kraker RT, Beck RW, Clarke MP, Lorenzana IJ, Petersen DB, Roberts JT, Suh DW. A randomized trial of increasing patching for amblyopia. Ophthalmology. 2013 Nov;120(11):2270-7. doi: 10.1016/j.ophtha.2013.04.008. Epub 2013 Jun 4.

  PMID: 23755872 RESULT

MeSH Terms

Conditions

Amblyopia; Bites and Stings

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; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Limitations and Caveats

A potential study limitation is that compliance with patching was based on discussions with the parent and by reviewing study calendars maintained by the parent, which not an objective measure of compliance.

Results Point of Contact

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

rkraker@jaeb.org

(813) 975-8690

Study Officials

• David K. Wallace, M.D.

  Duke University Eye Center

  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: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 13, 2016
• Results First Posted: November 13, 2013

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)