Combined Patching-Atropine for Residual Amblyopia

NCT00506675 | Terminated Phase 3 Results DMC

• 2 other identifiers: NEI-1352U10EY011751
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to \< 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia. The primary outcome assessment is amblyopic eye visual acuity at 10 weeks. The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.

Conditions

Amblyopia

Keywords

Amblyopia; Atropine; Patching

Outcome Measures

Primary Outcomes (4)

• Distribution of Amblyopic Eye Visual Acuity at 10 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).

  10 Weeks

• Mean (SD) Distribution of Visual Acuity at 10 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).

  10 Weeks

• Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks

  Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.

  baseline to 10 Weeks

• Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam

  Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.

  baseline to 10 Weeks

Study Arms (2)

Intensive

ACTIVE COMPARATOR

42 hours per week of patching combined with atropine (1%) once daily in the sound eye, with spectacle correction (if needed)

Device: Patching; Drug: Atropine

Weaning

ACTIVE COMPARATOR

For patients currently patching, reduce patching to two hours daily for four weeks, then no treatment thereafter except spectacle correction (if needed). For patients currently using atropine, reduce atropine to once weekly for 4 weeks, then no treatment thereafter except spectacle correction (if needed)

Device: Patching; Drug: Atropine

Interventions

Patching DEVICE

42 hours per week of patching

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

Intensive

Atropine DRUG

daily atropine (1%)

Intensive

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
• Visual acuity in the amblyopic eye between 20/32 and 20/63 inclusive
• Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference \>= 2 logMAR lines
• Current/previous treatment with patching and/or atropine subject to the following stipulations:
• No simultaneous treatment with patching and atropine in the past 6 months
• No prior use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
• Maximum level of any previous treatment:
• Patching: up to 42 hours per week (averaging 6 hours daily)
• Atropine: up to once daily
• Current treatment with 42 hours per week patching or daily atropine
• No improvement in best-corrected amblyopic eye visual acuity between two consecutive visits at least 6 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement defined as follows:
• No lines of improvement
• For patients tested using E-ETDRS, letter score that is no more than 4 letters improved
• Wearing spectacles with optimal correction (if applicable)

You may not qualify if:

• Current vision therapy or orthoptics
• Ocular cause for reduced visual acuity
• Prior intraocular or refractive surgery
• Strabismus surgery planned within 10 weeks
• Known allergy to atropine or other cycloplegic drugs
• Known skin reactions to patch or bandage adhesives
• Down Syndrome present

Sponsors & Collaborators

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

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Pediatric Eye Disease Investigator Group (PEDIG) Writing Committee; Wallace DK, Kraker RT, Beck RW, Cotter SA, Davis PL, Holmes JM, Repka MX, Suh DW. Randomized trial to evaluate combined patching and atropine for residual amblyopia. Arch Ophthalmol. 2011 Jul;129(7):960-2. doi: 10.1001/archophthalmol.2011.174. No abstract available.

  PMID: 21746992 RESULT

MeSH Terms

Conditions

Amblyopia

Interventions

Atropine

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

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

This trial was stopped after 18 months due to inadequate recruitment.

Results Point of Contact

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

pedig@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: PRINCIPAL INVESTIGATOR
• PI Title: Director, PEDIG Coordinating Center

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 25, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 13, 2016
• Results First Posted: March 23, 2011

Record last verified: 2016-07

Locations

US (1)