APPENDIX 9

Treatment Trials Quality Ratings

Study (Year)Random AssignmentAllocation ConcealedGroups Similar at BaselineEligibility Criteria SpecifiedBlinding PatientsBlinding ProvidersBlinding Outcome Assessors or Data AnalystsIntention-to-Treat AnalysisReporting of Attrition, ContaminationDifferential Loss to Follow-up, Overall High Loss to Follow-up, or Incomplete Follow-upFunding SourceExternal ValidityQuality Rating
Awan et al73 (2005)Cannot tellYesYesYesNoNoNoYesYesNoNational Eye Research Center; Ulverscroft FoundationMean age: 4.6 y; mean logMAR visual acuity, amblyopic eye: 0.64; mean logMAR visual acuity, sound eye: 0.02; strabismus: 27/60 (45%); mixed amblyopia 25/60 (42%)Fair
Clarke et al72 (2003)YesYesYesYesNoNoYesYesYesNoNational Health Service Research and DevelopmentMean age: 4.0 y; proportion of patients with anisometropia: 127/177 (72%); baseline logMAR visual acuity amblyopic eyea: 58/177 (33%) 0.18; 52/177 (29%) 0.30; 42/177 (24%) 0.48; 12/177 (7%) 0.60; 13/177 (7%) 0.78Good
PEDIG74 (2006)YesCannot tellYesYesNoNoYesYesYesNoNational Eye InstituteMean age: 5.3 y; 49.4% female; 81% white; 6% black; 9% Hispanic/Latino; 1% Asian; 3% mixed race; <1% unknown ethnicity; 89% no previous amblyopia treatment; 8% previous patching; <1% previous atropine; 2% previous patching and atropine; 23% strabismus; 47% anisometropia; 30% strabismus and anisometropia; mean logMAR visual acuity, amblyopic eye: 0.55 (SD: 0.23); approximate Snellen equivalent: 20/80; mean logMAR visual acuity, sound eye: 0.03 (SD: 0.11); approximate Snellen equivalent 20/20; mean refractive error, amblyopic eye: 4.92 (SD: 2.13); mean refractive error, sound eye: 2.72 (SD: 1.93)Good
PEDIG77 (2004)YesCannot tellYesYesNoNoYesYesYesNoNational Eye InstituteMean age: 5.3 y; 39% female; 79% white; 4% black; 12% Hispanic; 2% Asian; 1% American Indian/Alaskan Native; 1% mixed race; 2% unknown/not reported; strabismus 33%; anisometropia 41%; strabismus and anisometropia 23%; mean distance visual acuity (logMAR), amblyopic eye: 0.46 (SD: 0.10); mean distance visual acuity (logMAR), sound eye: 0.05 (SD: 0.10); mean refractive error, amblyopic eye: 4.22 (SD: 2.37); mean: refractive error, sound eye: 3.03 (SD 2.16)Good
PEDIG75 (2003)YesCannot tellYesYesNoNoYesYesYesNoNational Eye InstituteMean age: 5.2 y; 44% female; 85% white; 4% African American; 6% Hispanic; 1% Asian-American; 2% mixed race; 2% other; strabismus 40%; anisometropia 33%; strabismus and anisometropia 27%; mean sound eye visual acuity (logMAR): 0.07 (SD: 0.10); mean amblyopic eye visual acuity (logMAR): 0.48 (SD: 0.10); mean sound eye refractive error: 3.07 (SD: 2.35); Mean amblyopic eye refractive error: 4.12 (SD: 3.00)Good
PEDIG78 (2002)YesCannot tellYesYesNoNoYesYesYesNoNational Eye InstituteMean age: 5.3 y; 47% female; 83% white; 5% African American; 6% Hispanic; 2% Asian; 2% mixed; 2% other; 74% no previous amblyopia treatment; 20% previous patching; 2% previous atropine use; 0.2% previous patching + atropine use; 5% other previous treatment (including use of spectacle occluder and fogging); cause of amblyopia: 38% strabismus; 37% amblyopia; 24% strabismus and anisometropia; mean logMAR visual acuity, amblyopic eye: 0.53 (SD: 0.13); mean logMAR visual acuity, sound eye: 0.09 (SD: 0.11); mean intereye acuity difference (lines): 4.4 (SD: 1.3); mean refractive error, amblyopic eye: 4.46 (SD: 2.13); mean refractive error, sound eye: 2.82 (SD: 2.00)Good
Stewart et al76 (2007)YesCannot tellYesYesNoNoCannot tellYesYesNoFight for Sight United KingdomMean age: 5.6 y gender not reported; anisometropia 42/97 (43%); strabismus 21/97 (22%); mixed anisometropia and strabismus 34/97 (35%)Fair
  • a Converted from Snellen metric measures.