Combined Patching-Atropine for Residual Amblyopia

NCT ID: NCT00506675

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-09-30

Brief Summary

This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia.

The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.

The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.

Detailed Description

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional treatment, some patients fail to achieve normal visual acuity in the amblyopic eye. In a randomized trial conducted by PEDIG comparing atropine versus patching in 3 to 6 year olds with moderate amblyopia (ATS1), 261 of 402 patients (65%) had amblyopic eye visual acuity of 20/32 or worse after 6 months of treatment with patching or atropine. Beyond 6 months, treatment was at investigator discretion, and two years after randomization, 181 of 363 children (50%) still had amblyopic eye visual acuity of 20/32 or worse. In a randomized trial conducted by PEDIG comparing patching regimens, 129 of 181 patients with moderate amblyopia (71%) and 145 of 157 patients with severe amblyopia (92%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of occlusion therapy. Many patients receive treatment beyond 6 months but still fail to achieve normal visual acuity in the amblyopic eye. It is unknown whether an intensive "final push" of combined treatment with daily patching and atropine will improve visual acuity in these patients. Although some clinicians prescribe simultaneous patching and atropine for selected patients, there are no published reports of its effectiveness. Also, we are not aware of reports of response to treatment of residual amblyopia.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. Patients will be randomized to one of two treatment regimens:

• Intensive treatment: 42 hours per week of patching combined with daily atropine (1%)
• Control group: Weaning of the current treatment (two hours of daily patching for patients currently using patching and once weekly atropine for patients currently using atropine) for 4 weeks, then no treatment other than spectacles (if needed).

Conditions

Amblyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive

42 hours per week of patching combined with atropine (1%) once daily in the sound eye, with spectacle correction (if needed)

Group Type: ACTIVE_COMPARATOR

Patching

Intervention Type: DEVICE

42 hours per week of patching

Atropine

Intervention Type: DRUG

daily atropine (1%)

Weaning

For patients currently patching, reduce patching to two hours daily for four weeks, then no treatment thereafter except spectacle correction (if needed). For patients currently using atropine, reduce atropine to once weekly for 4 weeks, then no treatment thereafter except spectacle correction (if needed)

Group Type: ACTIVE_COMPARATOR

Patching

Intervention Type: DEVICE

two hours of daily patching for 4 weeks, then no treatment

Atropine

Intervention Type: DRUG

once weekly atropine for 4 weeks, then no treatment

Interventions

Patching

42 hours per week of patching

Intervention Type: DEVICE

Atropine

daily atropine (1%)

Intervention Type: DRUG

Patching

two hours of daily patching for 4 weeks, then no treatment

Intervention Type: DEVICE

Atropine

once weekly atropine for 4 weeks, then no treatment

Intervention Type: DRUG

Other Intervention Names

Coverlet, 3M Opticlude, Ortopad®; Coverlet, 3M Opticlude, Ortopad®

Eligibility Criteria

Inclusion Criteria

• Age 3 to < 10 years
• Amblyopia associated with strabismus, anisometropia, or both
• Visual acuity in the amblyopic eye between 20/32 and 20/63 inclusive
• Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >= 2 logMAR lines
• Current/previous treatment with patching and/or atropine subject to the following stipulations:

• No simultaneous treatment with patching and atropine in the past 6 months
• No prior use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
• Maximum level of any previous treatment:

• Patching: up to 42 hours per week (averaging 6 hours daily)
• Atropine: up to once daily
• Current treatment with 42 hours per week patching or daily atropine
• No improvement in best-corrected amblyopic eye visual acuity between two consecutive visits at least 6 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement defined as follows:

• No lines of improvement
• For patients tested using E-ETDRS, letter score that is no more than 4 letters improved
• Wearing spectacles with optimal correction (if applicable)
• Investigator ready to wean or stop treatment

Exclusion Criteria

• Current vision therapy or orthoptics
• Ocular cause for reduced visual acuity
• Prior intraocular or refractive surgery
• Strabismus surgery planned within 10 weeks
• Known allergy to atropine or other cycloplegic drugs
• Known skin reactions to patch or bandage adhesives
• Down Syndrome present

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Ray Kraker

Director, PEDIG Coordinating Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David K. Wallace, M.D.

Role: STUDY_CHAIR

Duke University Eye Center

Locations

Duke University Eye Center

Durham, North Carolina, United States

Countries

United States

References

Pediatric Eye Disease Investigator Group (PEDIG) Writing Committee; Wallace DK, Kraker RT, Beck RW, Cotter SA, Davis PL, Holmes JM, Repka MX, Suh DW. Randomized trial to evaluate combined patching and atropine for residual amblyopia. Arch Ophthalmol. 2011 Jul;129(7):960-2. doi: 10.1001/archophthalmol.2011.174. No abstract available.

Reference Type: RESULT

PMID: 21746992 (View on PubMed)

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NEI-135

Identifier Type: -

Identifier Source: org_study_id