Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

NCT00315328 | Completed Phase 3 Results DMC

• 2 other identifiers: NEI-1192U10EY011751
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is:

• To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to \<13 year olds.
• To determine the maximum improvement in vision of the amblyopic eye with each treatment.
• To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

Conditions

Amblyopia

Keywords

Amblyopia; Atropine; Patching

Outcome Measures

Primary Outcomes (4)

• Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks

  Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.

  17 weeks

• Mean Visual Acuity in the Amblyopic Eye at 17 Weeks

  Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.

  17 weeks

• Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks

  Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.

  Baseline to 17 weeks

• Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks

  Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.

  Baseline to 17 weeks

Secondary Outcomes (11)

• Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia

  17 or 19 weeks

• Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only

  17 or 19 weeks

• Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism

  17 or 19 weeks

• Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia

  17 or 19 weeks

• Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)

  17 weeks

Study Arms (2)

Patching

ACTIVE COMPARATOR

Patching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and \>4 hours per day for severe amblyopes at 5 weeks if acuity not improved at least 5 letters)

Device: Patching; Procedure: Near activities

Atropine

ACTIVE COMPARATOR

Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters)

Drug: Atropine; Procedure: Near activities

Interventions

Atropine DRUG

Atropine 1% each weekend day in the sound eye

Atropine

Patching DEVICE

Patching 2 hours per day

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

Patching

Near activities PROCEDURE

near visual activities for at least one hour per day

Atropine; Patching

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 7 to 12 years old (inclusive)
• Amblyopia associated with strabismus, anisometropia, or both
• Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)
• Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)
• Interocular difference \>=15 letters (3 lines)
• Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable
• Enrolled into the main study
• Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)
• Birth weight \>1500 grams
• No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

You may not qualify if:

• Amblyopia treatment (other than spectacles) in the last 6 months
• Myopia (more than -0.25D spherical equivalent) in either eye

Sponsors & Collaborators

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

Study Sites (2)

Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

• 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 BACKGROUND

• Repka MX, Kraker RT, Tamkins SM, Suh DW, Sala NA, Beck RW; Pediatric Eye Disease Investigator Group. Retinal nerve fiber layer thickness in amblyopic eyes. Am J Ophthalmol. 2009 Jul;148(1):143-7. doi: 10.1016/j.ajo.2009.01.015. Epub 2009 Mar 27.

  PMID: 19327749 BACKGROUND

• 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 BACKGROUND

• Felius J, Chandler DL, Holmes JM, Chu RH, Cole SR, Hill M, Huang K, Kulp MT, Lazar EL, Matta NS, Melia M, Wallace DK; Pediatric Eye Disease Investigator Group. Evaluating the burden of amblyopia treatment from the parent and child's perspective. J AAPOS. 2010 Oct;14(5):389-95. doi: 10.1016/j.jaapos.2010.07.009.

  PMID: 21035063 BACKGROUND

• Scheiman MM, Hertle RW, Kraker RT, Beck RW, Birch EE, Felius J, Holmes JM, Kundart J, Morrison DG, Repka MX, Tamkins SM; Pediatric Eye Disease Investigator Group. Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol. 2008 Dec;126(12):1634-42. doi: 10.1001/archophthalmol.2008.107.

  PMID: 19064841 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

Related Links

• PubMed Abstract
• PubMed Central HHS Public Access - Full Text

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

• Richard W. Hertle, M.D.

  University of Pittsburgh

  STUDY CHAIR

• Mitchell M. Scheiman, O.D.

  Pennsylvania College of Optometry

  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: August 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2008
• Last Updated: June 24, 2016
• Results First Posted: June 6, 2011

Record last verified: 2016-05

Locations

US (2)