Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia

NCT00000170 | Completed Phase 3 DMC

• 3 other identifiers: NEI-732U10EY0117515U10EY011751
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 1

Brief Summary

• To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy
• To develop more precise estimates of the success rates of amblyopia treatment
• To identify factors that may be associated with successful treatment of amblyopia
• To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients
• Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years.
• Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care

Conditions

Amblyopia

Keywords

Amblyopia; patching; atropine

Outcome Measures

Primary Outcomes (1)

• Visual acuity in the amblyopic eye

  6 months

Secondary Outcomes (3)

• Visual acuity in the amblyopic eye

  24 months

• Extended Follow-up: (Primary) To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years

  age 10 years and age 15 years

• Extended Follow-up: To determine whether the long-term visual acuity outcome at age 10 yrs and age 15 yrs differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care

  age 10 years and age 15 years

Study Arms (2)

Patching

ACTIVE COMPARATOR

Device: Eye Patch

Atropine

ACTIVE COMPARATOR

Atropine

Drug: Atropine

Interventions

Atropine DRUG

Atropine

Atropine

Eye Patch DEVICE

Patching

Patching

Eligibility Criteria

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

You may qualify if:

• Patients must be 7 years old or younger with amblyopia due to strabismus or anisometropia
• Visual acuity in the amblyopic eye must be between 20/40 and 20/100
• Visual acuity in the sound eye or 20/40 or better
• At least 3 lines of acuity difference between the two eyes

You may not qualify if:

• More than two months of amblyopia therapy in the past two years
• Myopia (more than -0.50 D)

Sponsors & Collaborators

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

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287-9028, United States

Location

Related Publications (16)

• Pediatric Eye Disease Investigator Group.. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2002 Mar;120(3):268-78. doi: 10.1001/archopht.120.3.268.

  PMID: 11879129 BACKGROUND

• Pediatric Eye Disease Investigator Group. The clinical profile of moderate amblyopia in children younger than 7 years. Arch Ophthalmol. 2002 Mar;120(3):281-7.

  PMID: 11879130 BACKGROUND

• Cole SR, Beck RW, Moke PS, Celano MP, Drews CD, Repka MX, Holmes JM, Birch EE, Kraker RT, Kip KE; Pediatric Eye Disease Investigator Group. The Amblyopia Treatment Index. J AAPOS. 2001 Aug;5(4):250-4. doi: 10.1067/mpa.2001.117097.

  PMID: 11507585 BACKGROUND

• Holmes JM, Beck RW, Repka MX, Leske DA, Kraker RT, Blair RC, Moke PS, Birch EE, Saunders RA, Hertle RW, Quinn GE, Simons KA, Miller JM; Pediatric Eye Disease Investigator Group. The amblyopia treatment study visual acuity testing protocol. Arch Ophthalmol. 2001 Sep;119(9):1345-53. doi: 10.1001/archopht.119.9.1345.

  PMID: 11545641 BACKGROUND

• Pediatric Eye Disease Investigator Group. A comparison of atropine and patching treatments for moderate amblyopia by patient age, cause of amblyopia, depth of amblyopia, and other factors. Ophthalmology. 2003 Aug;110(8):1632-7; discussion 1637-8. doi: 10.1016/S0161-6420(03)00500-1.

  PMID: 12917184 BACKGROUND

• Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with atropine in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):630-9. doi: 10.1016/s0002-9394(03)00458-6.

  PMID: 14516802 BACKGROUND

• Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with patching in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):620-9. doi: 10.1016/s0002-9394(03)00392-1.

  PMID: 14516801 BACKGROUND

• Holmes JM, Beck RW, Kraker RT, Cole SR, Repka MX, Birch EE, Felius J, Christiansen SP, Coats DK, Kulp MT; Pediatric Eye Disease Investigator Group. Impact of patching and atropine treatment on the child and family in the amblyopia treatment study. Arch Ophthalmol. 2003 Nov;121(11):1625-32. doi: 10.1001/archopht.121.11.1625.

  PMID: 14609923 BACKGROUND

• Repka MX, Wallace DK, Beck RW, Kraker RT, Birch EE, Cotter SA, Donahue S, Everett DF, Hertle RW, Holmes JM, Quinn GE, Scheiman MM, Weakley DR; Pediatric Eye Disease Investigator Group. Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2005 Feb;123(2):149-57. doi: 10.1001/archopht.123.2.149.

  PMID: 15710809 BACKGROUND

• Repka MX, Holmes JM, Melia BM, Beck RW, Gearinger MD, Tamkins SM, Wheeler DT; Pediatric Eye Disease Investigator Group. The effect of amblyopia therapy on ocular alignment. J AAPOS. 2005 Dec;9(6):542-5. doi: 10.1016/j.jaapos.2005.07.009.

  PMID: 16414520 BACKGROUND

• Repka MX, Melia M, Eibschitz-Tsimhoni M, London R, Magoon E; Pediatric Eye Disease Investigator Group. The effect on refractive error of unilateral atropine as compared with patching for the treatment of amblyopia. J AAPOS. 2007 Jun;11(3):300-2. doi: 10.1016/j.jaapos.2006.09.017.

  PMID: 17572346 BACKGROUND

• Pediatric Eye Disease Investigator Group; Repka MX, Kraker RT, Beck RW, Holmes JM, Cotter SA, Birch EE, Astle WF, Chandler DL, Felius J, Arnold RW, Tien DR, Glaser SR. A randomized trial of atropine vs patching for treatment of moderate amblyopia: follow-up at age 10 years. Arch Ophthalmol. 2008 Aug;126(8):1039-44. doi: 10.1001/archopht.126.8.1039.

  PMID: 18695096 BACKGROUND

• Repka MX, Kraker RT, Beck RW, Cotter SA, Holmes JM, Arnold RW, Astle WF, Sala NA, Tien DR; Pediatric Eye Disease Investigator Group. Monocular oral reading performance after amblyopia treatment in children. Am J Ophthalmol. 2008 Dec;146(6):942-7. doi: 10.1016/j.ajo.2008.06.022. Epub 2008 Aug 16.

  PMID: 18708179 BACKGROUND

• Repka MX, Kraker RT, Holmes JM, Summers AI, Glaser SR, Barnhardt CN, Tien DR; Pediatric Eye Disease Investigator Group. Atropine vs patching for treatment of moderate amblyopia: follow-up at 15 years of age of a randomized clinical trial. JAMA Ophthalmol. 2014 Jul;132(7):799-805. doi: 10.1001/jamaophthalmol.2014.392.

  PMID: 24789375 DERIVED

• Kulp MT, Foster NC, Holmes JM, Kraker RT, Melia BM, Repka MX, Tien DR; Pediatric Eye Disease Investigator Group. Effect of ocular alignment on emmetropization in children <10 years with amblyopia. Am J Ophthalmol. 2012 Aug;154(2):297-302.e1. doi: 10.1016/j.ajo.2012.02.035. Epub 2012 May 23.

  PMID: 22633344 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

Study Officials

• Michael X. Repka, M.D.

  Wilmer Eye Institute

  STUDY CHAIR

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: September 23, 1999
• First Posted: September 24, 1999
• Study Start: April 1, 1999
• Primary Completion: November 1, 2001
• Study Completion: August 1, 2013
• Last Updated: March 6, 2014

Record last verified: 2014-03

Locations

US (1)