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Evidence Based Treatment of Amblyopia in 2005 What we have learnt from the Pediatric Eye Disease Investigator Group [PEDIG] Lionel Kowal 1 Rationale for PEDIG Amblyopia Studies • Amblyopia is the most common cause of monocular visual impairment in children. • Existing data on the treatment of amblyopia largely retrospective / uncontrolled. 2 PEDIG : Network of community & university- based ophthalmologists and optometrists • A Randomized Trial of Atropine Versus Patching for Treatment of Moderate Amblyopia in Children - ATS 1 • A Randomized Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia - ATS 2A • A Randomized Trial Comparing Part-time Versus Minimaltime Patching for Moderate Amblyopia - ATS 2B • Prospective Study of Recidivism After Cessation of Amblyopia Treatment - ATS 2C • An Evaluation of Treatment of Amblyopia in Children 7-<18 Years Old – ATS3 • A Randomized Trial of Atropine Regimens for Treatment of Moderate Amblyopia in Children – ATS4 3 Amblyopia Treatment Study ATS 1 A Randomized Trial of Atropine Versus Patching for Treatment of Moderate Amblyopia in Children The Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs patching for treatment of moderate pamblyopia Archives of Ophthalmology 2002;120:268-278 ATS1 4 Objectives • To compare patching and atropine as treatments for moderate amblyopia in children 3 to <7 years old • To develop estimates of the success rates of treatment • To identify factors that may be associated with successful treatment ATS1 5 Study Design • A randomized, controlled single-masked multi-center clinical trial • 2 treatment groups Patching Atropine • Primary outcome: VA @ 6 mo • Treatment after 6 mo: investigator discretion ATS1 6 Eligibility Able to measure VA with single surrounded HOTV • Strabismic and/or anisometropic amblyopia • Visual Acuity: – Amblyopic eye: 6/12 to 6/30 – Sound eye: 6/12 or better – 3 lines or more interocular difference • < 2 mo of amblyopia therapy in prior 2 y ATS1 7 Electronic Visual Acuity Tester 20/400 ATS1 20/200 20/100 20/50 Holmes, JM, Beck, RW, et al The Amblyopia Treatment Study Visual Acuity Testing Protocol Archives of Ophthalmology 2001:119;1345-1353. 20/25 8 Patching Treatment • Initial – 6 h/d up to all waking hours at investigator’s discretion • Subsequent (@ 17 w) – If <6/9 and <3 line improvement, increase up to all or all but one waking hours – If >6/9 or >3 line improvement, investigator could decrease patching to a minimum of 1 h/d ATS1 9 Atropine Treatment • Initial – 1 drop atropine 1% daily in sound eye • Subsequent (@ 17 w) – If <6/9 and <3 line improvement, replace hypermetropic lens of sound eye with plano – If >6/9 or >3 line improvement, investigator could decrease atropine to 2/w ATS1 10 Amblyopia Treatment Index • Questionnaire of 18 items, each scored from 1 to 5, with 5 representing the most difficult • Three subscales measured adverse effects of treatment difficulties with compliance social stigma of treatment • Items are summed to create each subscale score, then scaled to a common range The Pediatric Eye Disease Investigator Group Impact of Patching and Atropine Treatment on the Child and Family in the Amblyopia Treatment Study Archives of Ophthalmology 2003:121;1625-1632 ATS1 11 Patient Characteristics N=419 ATS1 Female 47% Caucasian 83% African American 5% Hispanic 6% Asian 2% Mixed 2% Other 2% 12 Age ATS1 n=419 <3 y 2% 3 to <4 y 15% 4 to <5 y 20% 5 to <6 y 33% 6 to <7 y 30% Mean Age 5.3 y 13 Cause of Amblyopia n=419 Strabismus 38% Anisometropia 37% Combined-mechanism 24% Prior Treatment 26% received previous treatment for amblyopia ATS1 14 Patient Follow Up Patients Randomized 419 Patching Group 215 Atropine Group 204 6 Month Exam Completed 208 (97%) 6 Month Exam Completed 194 (95%) 2 Year Exam Completed 187 (87%) 2 Year Exam Completed 176 (86%) ATS1 15 Patching Group: Number of Hours of Patching Prescribed At Enrollment Maximum >=12 hours >=12 hours 20% 10 hours 7% 6 hours 33% 6-7 hours 43% 10% 27% 30% 8 hours 30% 10-11 hours 8-9 hours The number of hours prescribed at baseline was the maximum for 80% of patients ATS1 16 Atropine Group • All patients prescribed one drop of 1% atropine daily • A plano spectacle lens was prescribed for the sound eye during follow up for 56 /194 patients ATS1 17 Amblyopic Eye Acuity at 6 Months Mean improvement from baseline Mean acuity at 6 months (Snellen approximation) >6/9 or >3 line improvement from baseline ATS1 Patching Atropine (N=208) (N=194) 3.16 lines 2.84 lines 6/9 79% 6/9-2 74% 18 Amblyopic Eye at 6 Months Amblyopic Eye Visual Acuity Cumulative Distribution 100% Patching N=208 80% 60% Atropine 40% N=194 20% 0% >20/16 >20/20 >20/25 >20/32 >20/40 >20/50 >20/63 >20/80 >20/100 >20/125 >20/160 6-month Amblyopic Eye Visual Acuity ATS1 19 Amblyopic Eye Mean Acuity at Each Visit Patching Atropine 20/20 20/25 20/30- 20/30 20/40 20/40 20/40+ 20/50 20/60 20/30 20/30-2 20/50+ 20/60- 20/80 0 wks ATS1 5 wks 16 wks 6 mos 20 Treatment Effect in Subgroups at 6 Months • Effect of treatment was similar in subgroups based on: • Age: – <5 years old, >5 years old • Cause of amblyopia: – strabismus, anisometropia, combined • Baseline visual acuity in amblyopic eye – 20/80 to 20/100 , 20/40 to 20/60 ATS1 21 Effect of Treatment on Sound Eye at 6 Months • A decrease in visual acuity of 1 or more lines at 6 months: patching - 17 patients (8%) atropine - 47 patients (23%) • Some cases were due to improper refractive correction • In other cases there likely was residual cycloplegia from atropine not having been discontinued ATS1 22 Atropine Side Effects* N=208 Ocular Side Effects Any ocular side effect 26% Types of ocular side effects Lid/conjunctival irritation Light sensitivity Eye pain/headache Other 4% 18% 2% 2% Facial Flushing 2% Systemic Side Effects 3% * Reported at any visit in first 6 months ATS1 23 Patching Side Effects* N=215 Skin Irritation Mild 41% Moderate/Severe 6% * Reported at any visit in first 6 months ATS1 24 Amblyopia Treatment Index • Both treatments were well tolerated • All 3 subscale scores were consistently worse in the patching group Subscale Median Score Patching Atropine Adverse Effects 2.25 2.00 Difficulty with Compliance 2.20 1.80 Social Stigma 3.00 2.00 ATS1 25 Amblyopic Eye Acuity at 2 Years Patching Atropine (N=188) (N=179) Mean improvement from baseline 3.7 lines 3.6 lines Mean acuity at 2 years (Snellen approximation) 20/32+2 20/32+1 86% 84% >20/32 or >3 line improvement from baseline ATS1 Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2005 Feb;123(2):149-57. 26 Amblyopic Eye at 2 Years Amblyopic Eye Visual Acuity Cumulative Distribution 100% Patching N=188 80% 60% Atropine 40% N=176 20% 0% >20/16 ATS1 >20/20 >20/25 >20/32 >20/40 >20/50 >20/63 >20/80 >20/100 >20/125 >20/160 6-month Amblyopic Eye Visual Acuity 27 Summary • There was substantial improvement in amblyopic eye visual acuity with both treatments • Improvement was more rapid in the patching group • The difference between groups in amblyopic eye acuity at six months was small (about a third of a line) • There was no difference between groups in amblyopic eye acuity after 2 years ATS1 28 Amblyopia Treatment Study ATS 2A, 2B, 2C AN EVALUATION OF PATCHING REGIMENS ATS2 29 Rationale • Patching is most commonly prescribed. However, controversy exists concerning how much treatment is necessary. • Most data on the response according to the daily dosage of patching are retrospective and uncontrolled. • There is no standard of care once initial treatment of amblyopia is completed. ATS2 30 Randomized Trials Patching 2 hours versus 6 hours daily for moderate amblyopia (20/40 to 20/80) Patching 6 hours versus full-time for severe amblyopia (20/100 to 20/400) ATS2 31 Eligibility • Age < 7 years • Able to measure visual acuity with single surrounded HOTV optotypes • Strabismic and/or anisometropic amblyopia • Visual acuity: – Amblyopic eye: 20/40 to 20/400 – Sound eye: 20/40 or better – 3 lines or more interocular difference • No more than 2 months of amblyopia therapy in prior 2 years ATS2 32 Study Design Severe Amblyopia Trial 20/100-20/400 Randomize Full-time patching all or all but 1 hr per day Part-time patching 6 hrs per day Moderate Amblyopia Trial 20/40-20/80 Randomize Part-time patching 6 hrs per day Minimal-time patching 2 hrs per day Visit A: 5 ± 1 week Visual acuity testing both eyes Ocular alignment assessment Amblyopia Treatment Index ATS2 Visit B: 17 ± 1 week Visual acuity testing (masked) both eyes Ocular alignment assessment Stereoacuity Testing 33 Treatment Protocol Severe amblyopia: 6 hours of patching Full time patching Moderate amblyopia: 2 hours of patching 6 hours of patching All treatment groups were prescribed at least 1 hour of near activities while patching. Investigator - Patching decreased to no less than 7 hours per week Investigator - Patching could be continued, reduced, or stopped ATS2 34 Results ATS 2B 2 vs. 6 hours of patching for moderate amblyopia (20/40 – 20/80) The Pediatric Eye Disease Investigator Group A Randomized Trial of Patching Regimens for Treatment of Moderate Amblyopia in Children Archives Of Ophthalmology 121:2003;603-611 ATS2B 35 Patient Characteristics N=189 Female 44% Caucasian 85% Age (mean) 5.2 years Cause of Amblyopia Strabismus 40% Anisometropia 33% Combined 27% Prior Amblyopia Treatment ATS2B 14% 36 Patient Follow Up Patients Randomized N=189 2 Hour Group n=95 Completed n=92 (97%) ATS2B 6 Hour Group n=94 4-MONTH MASKED EXAM Completed n=89 (95%) 37 Amblyopic Eye Acuity at 4 Months 2 Hours Patching N=92 6 Hours Patching N=89 Mean improvement from baseline 2.4 lines 2.4 lines Mean acuity at 4 months (Snellen approximation) >20/32 or >3 line improvement from baseline ATS2B 20/32 62% -2 20/32 -2 62% 38 Amblyopic Eye Mean Acuity at Each Visit Baseline 5 Weeks 4 Months Mean Visual Acuity Score 20/32 20/32-2 20/32-2 20/40+ 20/40+ 20/40 20/50 20/63 20/63+ 20/63+ 20/80 2 Hours N=95 ATS2B 6 Hours N=94 2 Hours N=87 6 Hours N=85 2 Hours N=92 6 Hours N=89 39 Amblyopia Treatment Index • Both treatments were well tolerated. • The subscale scores were similar between the groups on the adverse event and treatment compliance subscales. • On the social stigma subscale, which includes questions related to the patch making the child feel different, the 6hour group was worse. Subscale Adverse Effects Median Score 2 Hours 6 Hours 2.13 2.13 Difficulty with Compliance 2.33 2.33 Social Stigma 2.67 3.00 ATS2B 40 Summary 2 vs. 6 hours for moderate amblyopia • Amblyopia improved with both patching regimens, when combined with prescribing 1 hour of near activities • There was no demonstrable advantage to the greater number of hours either in the rapidity or magnitude of improvement after 4 months of treatment ATS2B 41 Summary - Adverse Effects • We found no indication that 6 hours of patching compared with 2 hours of patching was associated with a higher rate of adverse effects on the sound eye acuity • New heterotropias were rare ATS2B 42 Conclusions • When combined with prescribing 1 hour of near activities, 2 hours of daily patching appears to be as effective as 6 hours of daily patching in treating moderate amblyopia in children 3 to < 7 years of age • A shorter duration of patching may ease the implementation of patching therapy and monitoring compliance for some parents ATS2B 43 Results ATS 2A 6 hours vs. full time patching for severe amblyopia (20/100 – 20/400) The Pediatric Eye Disease Investigator Group A Randomized Trial of Prescribed Patching Regimens for Treatment of Severe Amblyopia in Children Ophthalmology 2003:11;2075-2087 ATS2A 44 Patient Characteristics N= 175 Female 46% Caucasian 83% Age (mean) 4.8 years Cause of Amblyopia Strabismus 27% Anisometropia 34% Combined 38% Prior Amblyopia Treatment ATS2A 14% 45 Patient Follow Up Patients Randomized N=175 6 Hour Group n=85 Completed n=73 (86%) ATS2A Full-time Group n=90 4-MONTH MASKED EXAM Completed n=84 (93%) 46 Amblyopic Eye Acuity at 4 Months 6 Hours Patching N=73 Full-time Patching N=84 Mean improvement from baseline 4.8 lines 4.7 lines Mean acuity at 4 months (Snellen approximation) ATS2A 20/50 20/50 -2 47 Amblyopic Eye Mean Acuity at Each Visit Baseline Exam Five-week Exam Four-month Exam 20/040 Mean Visual Acuity Score 20/050 20/50 20/063 20/63-2 20/50-2 20/63-2 20/080 20/100 20/125 20/160+1 20/160 20/160 20/200 20/250 ATS2A Sixhrs N=85 Fulltime N=90 Sixhrs N=75 Fulltime N=77 Sixhrs N=73 Fulltime N=84 48 Treatment Effect in Subgroups at 4 Months Effect of treatment was similar in subgroups based on: • Age: – <5 years old, >5 years old • Cause of amblyopia: – strabismus, anisometropia, combined • Baseline visual acuity in amblyopic eye – 20/100 to 20/160 , 20/200 to 20/400 ATS2A 49 Amblyopia Treatment Index • Both treatments were well tolerated • The subscale scores were similar between the groups on the adverse event, treatment compliance, and social stigma subscale subscales Subscale Adverse Effects Median Score 6 Hours Full-Time 2.25 2.50 Difficulty with Compliance 2.33 2.42 Social Stigma 3.00 3.00 ATS2A 50 Summary 6 hrs vs. full-time for severe amblyopia • Amblyopia improved with both prescribed patching regimens, when combined with prescribing 1 hour of near activities • Compared to 6-hour patching, there was no demonstrable advantage to full-time patching in the rapidity or the magnitude of improvement after 4 months of treatment ATS2A 51 Amblyopia Recurrence ATS 2C • Prospective observational study • 156 children with successfully treated amblyopia – ready to stop treatment • Treatment STOPPED at enrollment Risk of amblyopia recurrence after cessation of treatment. J AAPOS. 2004 Oct;8(5):420-8. 52 Study Design Enrollment 156 children 5w Study period – off treatment 13w 26w 52w Previous Rx Treatment STOPPED 53 Recurrence overall during 1-year follow-up Recurrence ( 2 logMAR Confirmed by repeat testing) 21% (95% CI 14% to 28%) 21% 3% Alternative Definition – Non replicated 2 logMAR VA No recurrence All recurrences - 24% (95% CI 17% to 32%) 54 Timing of the 35 recurrences 150 140 Pts 14 (40%) 130 10 (29%) 120 5 (14%) 110 6 (17%) 100 0 5 10 15 20 25 30 Weeks 35 40 45 50 55 Patching vs Atropine Patching Stopped (77% pts) Atropine Stopped (23% pts) 21% 25% 75% 25% Recurrence (95% CI 17% to 34%) 79% 21% Recurrence (95% CI 7% to 35%) 56 Patching hours stopped Recurrence 15% 18% 43% 43% >2<6h 6-8h >8h 100% 80% 60% 40% 20% 0% 2h P=0.008 Patching hours stopped at enrollment57 Conclusions of Amblyopia Recurrence Study • ¼ of successfully amblyopic children experience a recurrence over 1 year of f/u • Recurrence risk is similar for stopping patching and atropine • Most recurrences occur within 3 months – early follow-up is critical – but long term follow-up is also important • If 6 or more hours of patching stopped – recurrence risk is lower if patching is reduced to 2 hours per day before cessation – suggests “weaning” is beneficial 58 An Evaluation of Treatment of Amblyopia in Children 7-<18 Years Old – ATS3 Supported by the National Eye Institute ATS3 59 PEDIG Pilot Study A prospective, pilot study of treatment of amblyopia in children 10 to <18 years old. Am J Ophthalmol. 2004:137;581-583. Eligibility • Age 10 to <18 years • Amblyopic eye acuity of 20/40 to 20/160 Treatment • >2 hours daily patching • At least one hour of near activities during patching Outcome: Visual acuity after two months of treatment Results: Visual acuity improved >2 lines in 18 (27%) of 66 patients ATS3PS 60 Objectives • To determine the response rate to amblyopia treatment in children from 7 to <18 years • To determine the frequency of recidivism of successfully-treated amblyopia in children 7 to <18 years ATS3 61 Eligibility • Age 7 years to <18 years • Amblyopia associated with strabismus, anisometropia, or both • Best corrected visual acuity in the amblyopic eye 20/40 to 20/400 • Best corrected visual acuity in the sound eye 20/25 or better • No myopia in amblyopic eye >-6.00 D spherical equivalent • No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the last 6 months ATS3 62 Study Design • Randomized, controlled multi-center clinical trial • Sample size: >360 children (>90 in each of 4 age groups) • Treatment groups: Control Group: Optical correction only Active Group: Optical correction Patching plus near activities Atropine (patients <13 yrs only) • Primary analysis: Comparison of proportion of treatment responders between treatment groups ATS3 63 Study Flow Enrollment Prescription of spectacles Randomization (within 30 days of enrollment) Visual acuity testing in new spectacles Randomized Trial Follow Up Responders Nonresponders Post-randomized Trial Follow Up Active Group Control Group End of Study Observation Phase Follow Up Treatment is discontinued ATS3 64 Enrollment/Randomization Screening/Enrollment Visit: • Patients are prescribed new spectacles (if needed) Randomization Visit (within 1 month): • New spectacles are placed on patient for the first time • Visual acuity is tested using E-ETDRS protocol, which yields a letter score • Patient is randomized as long as visual acuity still meets eligibility criteria ATS3 65 Treatment Groups Patients are randomized to one of the following treatment groups: Control Group: • Optical correction only Active Treatment Group: • Optical correction • Patching 2-6 hours daily • At least 1 hour of near activities daily during patching • Atropine 1% one drop daily (pts <13 yrs only) ATS3 66 Randomized Trial Follow Up Follow-up visits occur every 6 weeks up to 24 weeks • Visual acuity is tested with the E-ETDRS protocol • Using the best of two measured amblyopic eye visual acuities, the patient is classified as a responder, nonresponder or neither • When the patient meets criteria for either responder or non-responder and this is confirmed by masked exam, the randomized trial is over ATS3 67 Responder/Nonresponder Criteria Responder Criteria: 10 letter (2 line) or more improvement in amblyopic eye acuity compared with acuity at randomization Nonresponder Criteria: minimal improvement that is visit specific, but less than 10 letters by 24 weeks ATS3 68 Post-Randomized Trial Nonresponders: – End study follow up – Control group patients may start on active treatment outside study Responders: – Continue assigned treatment until no further improvement – Once improvement has stopped: • Control Group patients end study, but may start on active treatment outside study • Active Treatment Group patients discontinue treatment and enter the Observation Phase ATS3 69 Observation Phase Visits occur at 13 wks, 26 weeks, and 52 weeks after treatment discontinuation • Visual acuity is assessed at each visit • Recurrence: acuity 10 or more letters worse than acuity at treatment discontinuation ATS3 70 RESULTS • 507 patients • 49 sites – 1 to 33 patients/per site 71 Patient Characteristics 7 < 13 YRS N=404 (%) AGE FEMALE NO PRIOR TREATMENT CAUSE OF AMBLYOPIA Strabismus Anisometropia Combined ACUITY IN AMBLYOPIC EYE 20/200 - 400 20/100 – 160 20/40 – 80 TREATMENT (N = 201) 9.8 (1.6) 89 (44) 96 (48) OPTICAL CORRECTION (N = 203) 9.5 (1.7) 87 (43) 99 (49) 52 (26) 75 (38) 73 (37) 52 (26) 81 (41) 66 (33) 16 (8) 44 (22) 141 (70) 18 (9) 48 (24) 137 (67) 72 Patient Characteristics 13 < 18 YRS N=103 (%) AGE FEMALE NO PRIOR TREATMENT CAUSE OF AMBLYOPIA Strabismus Anisometropia Combined ACUITY IN AMBLYOPIC EYE 20/200 - 400 20/100 – 160 20/40 – 80 TREATMENT (N = 55) 14.7 (1.4) 31 (56) 36 (65) OPTICAL CORRECTION (N = 48) 14.9 (1.2) 25 (52) 33 (69) 11 (20) 20 (36) 24 (44) 14 (29) 17 (35) 17 (35) 2 (4) 20 (36) 33 (60) 3 (6) 16 (33) 29 (60) 73 Responder Rate 7 < 13 YRS TOTAL AMBLYOPIA LEVEL 20/40 – 80 (N 141/137) 20/100-400 (N 60/66) TREATMENT (N = 201) 106 (53) OPTICAL CORRECTION (N = 203) 50 (25) 70 (50) 36 (60) 30 (22) 20 (30) 42 (40) 64 (67) 14 (13) 36 (36) PRIOR AMBLYOPIA TREATMENT Yes (N 105/104) No (N 96/99) * All Statistically Different N (%) 74 Responder Rate 13 < 18 YRS TOTAL AMBLYOPIA LEVEL 20/40 – 80 (N 33/29) 20/100-400 (N 22/19) TREATMENT (N = 55) 14 (25) OPTICAL CORRECTION (N = 48) 11 (23) 7 (21) 7 (32) 6 (21) 5 (26) 6 (16) 8 (47) * 7 (25) 4 (20) * PRIOR AMBLYOPIA TREATMENT Yes (N 38/28) No (N 17/20) * * Suggestive of Difference N (%) 75 Conclusions • Amblyopic vision improves with optical correction alone in about ¼ of all 7 to 17 Year Olds and ½ of 7 to 12 years olds with additional treatment. • Amblyopic vision improves in 7 to < 13 year old children but not 13 to < 18 year olds who have been treated previously. • All amblyopic eyes have remaining visual deficit. • Persistence of effect after treatment cessation is unknown. 76 Amblyopia Treatment Study 4 (ATS4) A Randomized Trial of Atropine Regimens for Treatment of Moderate Amblyopia in Children 77 Study Objectives • To compare daily versus weekend atropine (twodays) for moderate amblyopia (20/40 to 20/80) in children 3 to <7 years old • To determine the maximum amount of improvement that could be achieved with these atropine schedules. 78 Study Design • A randomized, controlled, single-masked multicenter clinical trial weekend atropine • 2 treatment groups: daily atropine • Primary outcome: Visual acuity at 4 months • Secondary outcome: Maximum visual acuity improvement 79 Eligibility • Age < 7 years • Able to measure visual acuity with single surrounded HOTV optotypes • Strabismic and/or anisometropic amblyopia • No amblyopia treatment in the past month and no more than 1 month of amblyopia treatment in the past six months 80 Eligibility Visual Acuity • Amblyopic eye - 20/40 to 20/80 • Sound eye - > 20/40 • Inter-eye acuity difference - > 3 lines 81 Atropine Treatment • weekend or daily atropine 1% solution was prescribed • For patients in the daily atropine group, if the amblyopic eye acuity improved to be the same as or better than the sound eye acuity, atropine could be decreased to no less than twice per week 82 Visit Schedule • 5-week visit • Masked outcome visit at 4 months – Amblyopic eye at 17 weeks, sound eye and binocularity at 19 weeks • Additional visits at investigator discretion • Partial responders returned every 8 weeks 83 Patient Characteristics N=168 Female 39% Caucasian 79% Age (mean) 5.3 years Cause of Amblyopia Strabismus 33% Anisometropia 41% Combined 23% Prior Amblyopia Treatment 18% 84 Patient Follow-Up Patients Randomized N=168 Weekend Group n=85 Completed n=83 (98%) Daily Group n=83 4-MONTH MASKED EXAM Completed n=77 (93%) 85 Amblyopic Eye at 4 Months Weekend atropine N=83 Daily atropine N=77 Mean improvement from baseline 2.3 lines 2.3 lines Mean acuity at 4 months (Snellen approximation) >20/32 or >3 line improvement from baseline 20/32 66% -1 20/32 -1 66% 86 Amblyopic Eye at 4 Months Amblyopic Eye Visual Acuity Cumulative Distribution 100% 2-Hours Patching N=92 Weekend Atropine 80% N=83 Daily Atropine 60% N=77 6-Hours Patching 40% N=89 20% 0% >20/16 >20/20 >20/25 >20/32 >20/40 >20/50 >20/63 >20/80 >20/100 >20/125 >20/160 4-month Amblyopic Eye Visual Acuity 87 Amblyopic Eye Mean Acuity at Each Visit Baseline 5 Weeks Mean Visual Acuity Score 20/32 4 Months 20/32-1 20/40 20/40 20/32-1 20/40+1 20/50 20/63+2 20/63+2 20/63 Daily N=83 Weekend N=85 Daily N=78 Weekend N=81 Daily N=77 Weekend N=83 88 Acuity at Study Completion • 20/25 or better OR equal to sound eye – Daily - 39 (47%) – Weekend - 45 (53%) • Mean Amblyopic eye acuity – Daily – 0.23 logMAR (20/32-3) • 2.3 lines of improvement – Weekend – 0.21 log MAR (20/32-1) • 2.5 lines of improvement 89 Treatment Effect in Subgroups • Effect of treatment was similar in subgroups based on: • Age: – <5 years old, >5 years old • Cause of amblyopia: – strabismus, anisometropia, combined • Baseline visual acuity in amblyopic eye – <20/63, >20/50 90 Effect of Treatment on the Sound Eye • A decrease in sound eye visual acuity of 2 or more lines at 4 months: Weekend atropine - 2 patients (2.4%) Daily atropine - 2 patients (2.6%) • Further Follow-up Testing: • One in each group same as or better than baseline • One in each group 20/32 compared with 20/20 at baseline 91 Other adverse effects • Light sensitivity (no treatment changes) – Daily group – 13 (16%) – Weekend group – 25 (29%) • Facial flushing / fever – 2 patients in daily group – 1 stayed on treatment and 1 switched to homatropine 92 Ocular alignment • 2 in daily and none in weekend developed > 8D deviation • 2 in daily, 3 in weekend had disappearance of a microstrabismus • 10% developed new strabismus or a preexisting angle of strabismus that had increased by at least 10D • 8% had their strabismus resolved or reduced by at least 10D 93 Amblyopia Treatment Index • Both treatments were well tolerated. • The subscale scores were similar between the groups on the adverse event and social stigma subscales. • On the compliance subscale the weekend group was slightly worse. Subscale Median Score Weekend Daily Adverse Effects 2.00 2.00 Difficulty with Compliance 2.10 2.00 Social Stigma 2.00 2.00 94 Conclusions • Weekend atropine appears to be as effective as daily atropine in treating moderate amblyopia in children 3 to < 7 years of age • A reduced frequency is another alternative treatment for amblyopia. • The magnitude of the visual acuity improvement was similar to that seen for 2hour and 6-hour prescribed patching regimens for moderate amblyopia. 95