An Evaluation of Treatment of Amblyopia in Children 7 To <18 Years Old

Amblyopia Clinical Trial

Official title:

An Evaluation of Treatment of Amblyopia in 7 To <18 Year Olds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094692
• Other study ID #: NEI-93
• Secondary ID: 2U10EY011751
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2004
• Last updated: March 23, 2010
• Start date: October 2002
• Est. completion date: December 2005

Study information

• Verified date: May 2007
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The goals of this study are:

• To determine the response rate of treatment of amblyopia in 7 to <18 year olds.

• To determine the frequency of recurrence of amblyopia in 7 to <18 year olds after discontinuation of amblyopia treatment.

Description:

Most eye care practitioners believe that there is an age beyond which attempting to treat amblyopia is futile. It is generally held that the response to treatment is best when it is instituted at an early age and is poor when attempted after eight years of age. There has not been a prospective clinical trial conducted with appropriate rigor that has evaluated the effect of treatment of amblyopia in children aged 7 years or older. Although available data on the efficacy of amblyopia treatment of older children are limited, there is reason to believe from clinical observations and published case series that treatment could have benefit. In a pilot study of patients 10 to <18 years old with amblyopia, we found that 37 percent of 52 patients showed improvement in the amblyopic eye acuity of 2 or more lines after treatment with part-time patching. However, without a concurrent randomized control group, the results are not conclusive. Although the literature and our pilot study provide support that amblyopia can be improved with treatment, neither the response rate to treatment nor the recidivism rate after cessation of treatment can be well defined. Despite the evidence that amblyopia therapy can be effective in older children, many clinicians do not attempt treatment under the assumption that it will be unsuccessful. Therefore, a clinical trial is needed to provide the requisite data to establish clinical practice guidelines for the treatment of amblyopia in older children. In addition to its importance for patient management, the trial's results will meet the demand for cost effectiveness by health maintenance organizations, large employers, and insurers.

The study is a randomized trial comparing patients treated with spectacles only (Control Group) to patients undergoing active treatment (patching, near activities while patching, and atropine for children under the age of 13) in addition to spectacles (Active Treatment Group). It will enroll a minimum of 90 patients in each of the age groups of 7 to <9, 9 to <11, 11 to <13, and 13 to <18 years old. Patients have follow up visits every 6 weeks (up to a maximum of 24 weeks) until they are classified as either responders or nonresponders based on amblyopic eye visual acuity. At the end of the randomized trial:

• Patients who did not respond to treatment end follow up.

• Patients who responded to treatment continue in their respective treatment groups until visual acuity stops improving.

Once there is no further improvement in visual acuity:

• Patients in the Control Group end follow up

• Patients in the Active Treatment Group discontinue active treatment and have follow up visits at 13 weeks, 26 weeks, and 52 weeks timed from treatment discontinuation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients must be aged 7 to <18 years and have amblyopia associated with strabismus, anisometropia, or both.

• Visual acuity in the amblyopic eye must be 20/40 to 20/400 inclusive and visual acuity in the sound eye must be 20/25 or better.

Exclusion Criteria:

• Patients must not have received amblyopia treatment (other than spectacles) in the past month or more than one month of amblyopia treatment in the last 6 months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• Eye patch

• spectacles

Drug:
• atropine

Locations

Country	Name	City	State
United States	Wilmer Eye Institute	Baltimore	Maryland
United States	Pennsylvania College of Optometry	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hertle RW, Scheiman MM, Beck RW, Chandler DL, Bacal DA, Birch E, Chu RH, Holmes JM, Klimek DL, Lee KA, Repka MX, Weakley DR Jr; Pediatric Eye Disease Investigator Group. Stability of visual acuity improvement following discontinuation of amblyopia treatment in children aged 7 to 12 years. Arch Ophthalmol. 2007 May;125(5):655-9. — View Citation

Pediatric Eye Disease Investigator Group. A prospective, pilot study of treatment of amblyopia in children 10 to <18 years old. Am J Ophthalmol. 2004 Mar;137(3):581-3. — View Citation

Scheiman MM, Hertle RW, Beck RW, Edwards AR, Birch E, Cotter SA, Crouch ER Jr, Cruz OA, Davitt BV, Donahue S, Holmes JM, Lyon DW, Repka MX, Sala NA, Silbert DI, Suh DW, Tamkins SM; Pediatric Eye Disease Investigator Group. Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol. 2005 Apr;123(4):437-47. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity improvement