Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old

NCT00315302 | Completed Phase 3 Results DMC

• 2 other identifiers: NEI-1152U10EY011751
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is:

• To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
• To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

Conditions

Amblyopia

Keywords

Amblyopia; Atropine; Plano lens

Outcome Measures

Primary Outcomes (4)

• Visual Acuity Mean Score in the Amblyopic Eye

  Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst

  18 weeks

• Visual Acuity Distribution in the Amblyopic Eye

  Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis. 20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst

  18 weeks

• Mean Change in Visual Acuity in the Amblyopic Eye

  Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.

  baseline to 18 weeks

• Distribution of Change in Visual Acuity in the Amblyopic Eye

  Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.

  baseline to 18 weeks

Secondary Outcomes (5)

• Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia

  18 weeks

• Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only

  18 weeks

• Mean Change in Visual Acuity in the Sound Eye

  baseline to 18 weeks

• Distribution of Change in Visual Acuity in the Sound Eye

  baseline to 18 weeks

• Visual Acuity Distribution in the Sound Eye

  18 weeks

Study Arms (2)

Atropine

ACTIVE COMPARATOR

Atropine 1% once each weekend day in the sound eye

Drug: Atropine

Atropine plus plano

ACTIVE COMPARATOR

Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye

Drug: Atropine; Device: Plano Lens

Interventions

Atropine DRUG

Atropine 1% once each weekend day

Atropine; Atropine plus plano

Plano Lens DEVICE

Plano lens for the sound eye

Atropine plus plano

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.
• Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logMAR lines.
• Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

You may not qualify if:

• Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment
• No myopia in amblyopic eye

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

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (4)

• Pediatric Eye Disease Investigator Group. Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmol. 2009 Jan;127(1):22-30. doi: 10.1001/archophthalmol.2008.520.

  PMID: 19139333 RESULT

• Repka MX, Kraker RT, Beck RW, Birch E, Cotter SA, Holmes JM, Hertle RW, Hoover DL, Klimek DL, Marsh-Tootle W, Scheiman MM, Suh DW, Weakley DR; Pediatric Eye Disease Investigator Group. Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials. J AAPOS. 2009 Jun;13(3):258-63. doi: 10.1016/j.jaapos.2009.03.002.

  PMID: 19541265 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

• Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.

  PMID: 20451898 DERIVED

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

Results Point of Contact

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

pedig@jaeb.org

813-975-8690

Study Officials

• David Weakley, M.D.

  University of Texas Southwestern Medical Center

  STUDY CHAIR

• Susan A. Cotter, O.D.

  Southern California College of Optometry at Marshall B. Ketchum University

  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: April 14, 2006
• First Posted: April 18, 2006
• Study Start: February 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: January 1, 2008
• Last Updated: July 19, 2016
• Results First Posted: August 11, 2011

Record last verified: 2016-07

Locations

US (2)