Phase 3 N=233 Randomized Treatment

Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

Amblyopia

Bottom Line

View on ClinicalTrials.gov: NCT00315328 ↗

Enrolled (actual)

233

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcome: Primary: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks — 0; 0; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Atropine (Drug); Patching (Device); Near activities (Procedure)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: Jaeb Center for Health Research
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks	0; 0; 0; 0; 0; 0	—
PRIMARY Mean Visual Acuity in the Amblyopic Eye at 17 Weeks	71.0; 69.2; 46.0; 45.0	—
PRIMARY Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks	1; 0; 0; 0; 0; 2	—
PRIMARY Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks	8.6; 7.6; 9.0; 7.5	—
SECONDARY Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia	4; 9; 57; 54; 17; 18	.04 sig
SECONDARY Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only	0; 0; 5; 6; 3; 1	0.78
SECONDARY Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism	1; 4; 21; 28; 6; 2	0.99
SECONDARY Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia	4; 9; 57; 54; 17; 18	.04 sig
SECONDARY Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)	2.37; 1.91	<0.01 sig
SECONDARY Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)	2.59; 2.03	<0.01 sig
SECONDARY Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)	2.28; 2.22	0.70
SECONDARY Distribution of Visual Acuity in the Fellow Eye at 17 Weeks	0; 0; 0; 0; 0; 0	—
SECONDARY Mean Visual Acuity in the Fellow Eye at 17 Weeks	87.3; 85.8; 88.5; 86.5	—
SECONDARY Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks	0; 0; 0; 1; 4; 7	—
SECONDARY Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks	1.5; 0.3; 1.0; 1.0	—

Summary

The purpose of this study is: * To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds. * To determine the maximum improvement in vision of the amblyopic eye with each treatment. * To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

Eligibility Criteria

Inclusion Criteria

Age 7 to 12 years old (inclusive)
Amblyopia associated with strabismus, anisometropia, or both
Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)
Interocular difference >=15 letters (3 lines)
Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable

Inclusion Criteria for Optional Ancillary Study:

Enrolled into the main study
Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)
Birth weight >1500 grams
No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

Exclusion Criteria

Amblyopia treatment (other than spectacles) in the last 6 months
Myopia (more than -0.25D spherical equivalent) in either eye

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00315328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.