| Author, Year | N | Population | Setting | Exclusions | Definitions of Amblyopia | Intervention | Outcomes | Results | Study Quality |
|---|---|---|---|---|---|---|---|---|---|
| Pediatric Eye Disease Group, 20024 | 409 | Children aged 3-7 years with moderate amblyopia | 47 clinical sites in North America | Ocular cause for visual acuity; prior intraocular surgery; myopia in either eye; Down Syndrome; known skin reaction to patch or bandage adhesive, or allergy to atropine or other cycloplegics; more than 2 mos of amblyopia therapy in the past 2 yrs; aged 7 or older; not able to measure visual acuity with Amblyopia Treatment Study visual acuity testing protocol; refractive error not corrected for at least 4 wks; does not meet study criteria for amblyopia associated with strabismus, refractive error/anisometropia, or both | Amblyopia associated with strabismus, refractive error/anisometropia, or both; visual acuity in the amblyopic eye < 20/40 or > 20/100; visual acuity in the sound eye > 20/40; intereye acuity difference > to 3 logMAR lines | Visual acuity testing protocol 7 days prior to randomization to patch for 6 hrs/day or atropine sulfate 1% 1 drop/day; adjustments in treatment based on patient responses and study criteria; followup visits at 5, 16, 26 wks (primary outcome) with additional followup at 18 mos, with at least 1 visit every 6 mos | Visual acuity score in logMAR units in the amblyopic eye and sound eye after 6 mos of treatment; successful treatment defined by amblyopic eye's visual acuity 20/30 or better or improvement of 3 or more lines from baseline; also evaluated effect of treatment on child and parent by questionnaire, adherence to treatment, and adverse reactions | Improved visual acuity in the amblyopic eye in both the patching and atropine groups: patching group mean change in visual acuity was 3.16 lines (95% CI, 2.95-3.37); atropine group mean change in visual acuity was 2.84 lines (95% CI, 2.61-3.07); improvement occurred faster in the patch group; mean treatment group difference in 6 mos logMAR acuity was 0.034 (95% CI, 0.005-0.064); 79% of patching group and 74% of atropine group met criteria for treatment success (95% CI for differences in percentages, -4% to 13%); at 6 mos, visual acuity in the sound eye was decreased from baseline by 1 line in 14 patients (7%) in patching group; 30 patients (15%) in atropine group; and by 2 or more lines in 3 patients (1%) and 17 patients (9%), respectively (P < 0.001); this difference did not persist with further followup; both treatments were well tolerated; atropine had a slightly higher degree of acceptability on a parental questionnaire and better adherence than patching | Good |
Note: CI, confidence interval; RCT, randomized controlled trial. |
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