Increasing Patching for Amblyopia in Children 3 to < 8 Years Old

NCT ID: NCT00945100

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-03-31

Brief Summary

This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week). The primary objective is to determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

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.1 Many practitioners prescribe 2 hours daily patching as initial therapy for amblyopia. However, many children fail to achieve normal visual acuity in the amblyopic eye with this regimen. In a randomized trial conducted by PEDIG comparing patching regimens, 71 of 92 patients with moderate amblyopia (77%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of patching 2 hours daily.2 In another PEDIG randomized trial comparing patching to spectacles alone after a period of refractive adaptation, patients were treated with 2 hours daily patching and followed every 5 weeks until there was no improvement in amblyopic eye acuity. Fifty-five of 70 patients with moderate amblyopia (79%) and 14 of 14 patients with severe amblyopia (100%) had best-measured amblyopic eye visual acuity of 20/32 or worse after a median treatment period of 10 weeks.3 When improvement with initial therapy stops and amblyopia is still present, treatment options include increasing the dosage of current treatment, switching to another treatment, maintaining the same treatment and dosage for additional months, or combining treatments. Many clinicians will choose to increase the dosage of the current treatment, in part because families have become comfortable with that particular mode of treatment. However, it is unknown whether increasing occlusion dosage will improve amblyopic eye visual acuity in these patients. We are unaware of any reports of response to intensified treatment of amblyopia.

Conditions

Amblyopia

Study Design

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

Study Groups

Control

2 hours daily patching

Group Type: ACTIVE_COMPARATOR

Eye Patch

Intervention Type: DEVICE

2 hours patching daily

Intensified treatment

42 hours per week of patching (averaging 6 hours daily)

Group Type: ACTIVE_COMPARATOR

Eye Patch

Intervention Type: DEVICE

42 hours patching per week (averaging 6 hours patching daily)

Interventions

Eye Patch

42 hours patching per week (averaging 6 hours patching daily)

Intervention Type: DEVICE

Eye Patch

2 hours patching daily

Intervention Type: DEVICE

Other Intervention Names

Coverlet; 3M Opticlude; Ortopad; Coverlet; 3M Opticlude; Ortopad

Eligibility Criteria

Inclusion Criteria

Major Eligibility Criteria for Run-in Phase

• Age 3 to < 8 years
• Amblyopia associated with strabismus, anisometropia, or both
• Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
• Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines
• Amblyopia treatment within the past 6 months subject to the following stipulations:

• No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with 2 hours of patching per day who are entering the study on treatment)
• No simultaneous treatment with patching and atropine
• No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
• Maximum level of treatment within the past 6 months:

• Patching: up to 2 hours daily
• Atropine: up to once daily
• Wearing spectacles with optimal correction (if applicable); if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses. If amblyopic eye acuity is 20/100 or worse, then spectacles and patching can be initiated simultaneously.

Eligibility Criteria for Randomization:

• Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
• Reasonable compliance with prescribed treatment, defined as wearing the patch at least 10 hours per week.

Exclusion Criteria

• Currently using vision therapy or orthoptics
• Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
• Prior intraocular or refractive surgery
• Known skin reaction to patch or bandage adhesives

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 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

Responsibility Role: SPONSOR

Principal Investigators

David K. Wallace, M.D.

Role: STUDY_CHAIR

Duke University Eye Center

Locations

Southern California College of Optometry

Fullerton, California, United States

Duke University Eye Center

Durham, North Carolina, United States

Countries

United States

References

Wallace DK, Lazar EL, Crouch ER 3rd, Hoover DL, Kraker RT, Tamkins SM; Pediatric Eye Disease Investigator Group. Time course and predictors of amblyopia improvement with 2 hours of daily patching. JAMA Ophthalmol. 2015 May;133(5):606-9. doi: 10.1001/jamaophthalmol.2015.6. No abstract available.

Reference Type: BACKGROUND

PMID: 25695355 (View on PubMed)

Pediatric Eye Disease Investigator Group; Wallace DK, Lazar EL, Holmes JM, Repka MX, Cotter SA, Chen AM, Kraker RT, Beck RW, Clarke MP, Lorenzana IJ, Petersen DB, Roberts JT, Suh DW. A randomized trial of increasing patching for amblyopia. Ophthalmology. 2013 Nov;120(11):2270-7. doi: 10.1016/j.ophtha.2013.04.008. Epub 2013 Jun 4.

Reference Type: RESULT

PMID: 23755872 (View on PubMed)

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NEI-143

Identifier Type: -

Identifier Source: org_study_id