Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

NCT00944710 | Completed Phase 3 Results DMC

• 2 other identifiers: NEI-1442U10EY011751
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but 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 weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

Conditions

Amblyopia

Keywords

Amblyopia; atropine; Plano lens

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

  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 (22)

• Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization

  10 weeks after randomization

• 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

• Spectacle Compliance at 10 Weeks by Treatment Group

  10 weeks after randomization

• Average Spectacle Compliance by Treatment Group

  10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)

• Atropine Compliance at 10 Weeks by Treatment Group

  10 weeks after randomization

Study Arms (2)

Intensified treatment

ACTIVE COMPARATOR

Weekend atropine 1% with plano lens over the sound eye

Drug: Atropine; Device: Plano lens

Control

ACTIVE COMPARATOR

Weekend atropine 1%

Drug: Atropine

Interventions

Atropine DRUG

Weekend atropine 1%

Intensified treatment

Plano lens DEVICE

plano lens over the sound eye

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 atropine 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 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 atropine can be initiated simultaneously).
• Hypermetropia and spectacle correction in sound eye of +1.50 D or more
• Eligibility Criteria for Randomization:

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 allergy to atropine or other cycloplegic drugs
• Down Syndrome present

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 (1)

• Pediatric Eye Disease Investigator Group; Wallace DK, Lazar EL, Repka MX, Holmes JM, Kraker RT, Hoover DL, Weise KK, Waters AL, Rice ML, Peters RJ. A randomized trial of adding a plano lens to atropine for amblyopia. J AAPOS. 2015 Feb;19(1):42-8. doi: 10.1016/j.jaapos.2014.10.022.

  PMID: 25727586 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

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: 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

• 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: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 6, 2019
• Results First Posted: October 24, 2014

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)