Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00091923
First received: September 20, 2004
Last updated: March 23, 2010
Last verified: September 2009
  Purpose

The objectives of the Spectacle Phase are:

  • In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine

    1. the incidence of resolution of amblyopia with spectacle correction alone and
    2. the time course of visual acuity improvement with spectacle correction alone.
  • In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial.

The objectives of the Randomized Trial are:

  • To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400).
  • To determine the maximal improvement and time course of improvement with this patching treatment regimen.

Condition Intervention Phase
Amblyopia
Device: Eye patch
Device: Spectacles
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to <7 Years Old

Resource links provided by NLM:


Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • maximal improvement in visual acuity

Estimated Enrollment: 268
Study Start Date: February 2004
Study Completion Date: December 2005
Detailed Description:

There are few data on the improvement that occurs with spectacle correction alone in cases of anisometropic amblyopia. The only published study of which we are aware is that of Moseley, et al, who found that 8 of 12 patients prescribed spectacles for the first time improved 3 or more lines in the amblyopic eye. Therefore, the Spectacle Phase of the current study will provide important information related to the management of patients with anisometropic amblyopia.

Additionally, despite clinical experience that strongly indicates that amblyopia can be improved with treatment, there are those who claim that the benefit of treatment is unproven. Although improvement with amblyopia therapy has been shown in prospective trials, there have been no conclusive data published from a randomized trial evaluating the effect of amblyopia treatment compared with a control group. Therefore, we have designed a randomized trial to definitively address this issue.

In the trial, the effect on amblyopic eye acuity after five weeks of 2 hours of prescribed daily patching (combined with at least one hour of concurrent near activities) will be compared with a control group using spectacle correction only. In a study conducted by the Pediatric Eye Disease Investigator Group, a 2-hour daily patching treatment regimen improved moderate amblyopia (20/40 to 20/80) by an amount similar to the improvement seen with 6 hours of daily patching.

At the end of five weeks, patients whose amblyopic eye has improved from baseline will continue in follow up, using the assigned treatment, until the amblyopic eye acuity stops improving or until the amblyopia resolves. This will provide data on the maximum improvement achievable with this treatment regimen and on the time course to reach maximal improvement. There is no known harm in deferring treatment of amblyopia for five weeks in the age range to be included in the trial (3 to <7 years old). Standard care for a patient with amblyopia includes prescribing spectacle correction and having the patient return in 4 to 6 weeks for measurement of visual acuity. Spectacles alone are continued as long as the acuity in the amblyopic eye is improving. Once the acuity stops improving, occlusion or other active treatment is initiated. The maximum delay in active treatment of the control group beyond the standard of care is 5 weeks. In our prior Amblyopia Treatment Study protocols on patients in this age range, we have found no indication that the response to patching treatment is related to age. Therefore, it is highly unlikely that a delay in initiating treatment of weeks or even months could be harmful.

This study is addressing issues related to the treatment of amblyopia in children 3 to <7 years old with visual acuity 20/40 to 20/400. The study consists of two phases:

  1. a Spectacle Phase in which patients are prescribed spectacles and followed until maximal improvement in visual acuity has occurred and
  2. a Randomized Trial comparing a group using patching treatment (in addition to spectacle correction) with a control group using spectacle correction only.

The sample size for the primary analysis for the randomized trial has been estimated to be 134 patients. Patients will be enrolled into the Spectacle Phase until the recruitment goal for the Randomized Trial is reached.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 3 to <7 years
  • Able to perform visual acuity using the ATS single-surround HOTV protocol
  • Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
  • Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive
  • Visual acuity in the sound eye >20/40
  • Inter-eye acuity difference >3 logMAR lines
  • Cycloplegic refraction and ocular examination within 2 months prior to enrollment

Exclusion Criteria:

  • No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
  • No current vision therapy or orthoptics
  • No ocular cause for reduced visual acuity
  • No myopia more than a spherical equivalent of -6.00 D
  • No prior intraocular or refractive surgery
  • No known skin reactions to patch or bandage adhesives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091923

Locations
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
United States, North Carolina
Duke University Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
Study Chair: David K. Wallace, M.D. Duke University Eye Center
Study Chair: Susan A. Cotter, O.D. Southern California College of Optometry
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00091923     History of Changes
Other Study ID Numbers: NEI-96, 2U10EY011751, 5-U10 EY 11751
Study First Received: September 20, 2004
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014