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Evidence Based Treatment of Amblyopia in 2005

Evidence Based Treatment of Amblyopia in 2005. What we have learnt from the Pediatric Eye Disease Investigator Group [PEDIG] Lionel Kowal. Rationale for PEDIG Amblyopia Studies. Amblyopia is the most common cause of monocular visual impairment in children.

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Evidence Based Treatment of Amblyopia in 2005

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  1. Evidence Based Treatment of Amblyopia in 2005 What we have learnt from the Pediatric Eye Disease Investigator Group [PEDIG] Lionel Kowal

  2. 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.

  3. 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 Minimal-time 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

  4. Amblyopia Treatment StudyATS 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

  5. 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

  6. Study Design • A randomized, controlled single-masked multi-center clinical trial • 2 treatment groups • Primary outcome: VA @ 6 mo • Treatment after 6 mo: investigator discretion Patching Atropine ATS1

  7. 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

  8. Electronic Visual Acuity Tester 20/400 20/200 20/100 20/50 20/25 Holmes, JM, Beck, RW, et al The Amblyopia Treatment Study Visual Acuity Testing Protocol Archives of Ophthalmology 2001:119;1345-1353. ATS1

  9. 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

  10. 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

  11. 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

  12. Patient Characteristics N=419 Female 47% Caucasian 83% African American 5% Hispanic 6% Asian 2% Mixed 2% Other 2% ATS1

  13. Age 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 ATS1

  14. Cause of Amblyopia n=419 Strabismus 38% Anisometropia 37% Combined-mechanism 24% Prior Treatment 26% received previous treatment for amblyopia ATS1

  15. 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

  16. Patching Group: Number of Hours of Patching Prescribed At Enrollment Maximum >=12 hours >=12 hours 6 hours 6-7 hours 10 hours 8 hours 10-11 hours 8-9 hours The number of hours prescribed at baseline was the maximum for 80% of patients ATS1

  17. 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

  18. Amblyopic Eye Acuity at 6 Months Patching Atropine (N=208) (N=194) Mean improvement from 3.16 lines 2.84 lines baseline Mean acuity at 6 months 6/9 6/9-2 (Snellen approximation) >6/9 or >3 line improvement from baseline 79% 74% ATS1

  19. Amblyopic Eye at 6 Months N=208 Amblyopic Eye Visual Acuity Cumulative Distribution N=194 >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

  20. 0 wks 5 wks 16 wks 6 mos Amblyopic Eye Mean Acuity at Each Visit 20/20 20/25 20/30- 20/30 20/30 20/40 20/40 20/30-2 20/40+ 20/50 20/50+ 20/60 20/60- 20/80 ATS1

  21. 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

  22. 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

  23. Atropine Side Effects* N=208 Ocular Side Effects Any ocular side effect 26% Types of ocular side effects Lid/conjunctival irritation 4% Light sensitivity 18% Eye pain/headache 2% Other 2% Facial Flushing 2% Systemic Side Effects3% * Reported at any visit in first 6 months ATS1

  24. Patching Side Effects* N=215 Skin Irritation Mild 41% Moderate/Severe 6% * Reported at any visit in first 6 months ATS1

  25. Amblyopia Treatment Index • Both treatments were well tolerated • All 3 subscale scores were consistently worse in the patching group • Median Score • Subscale Patching Atropine • Adverse Effects 2.25 2.00 • Difficulty with Compliance 2.20 1.80 • Social Stigma 3.00 2.00 ATS1

  26. Amblyopic Eye Acuity at 2 Years Patching Atropine (N=188) (N=179) Mean improvement from 3.7 lines 3.6 lines baseline Mean acuity at 2 years 20/32+2 20/32+1 (Snellen approximation) >20/32 or >3 line improvement from baseline 86% 84% 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. ATS1

  27. Amblyopic Eye at 2 Years N=188 Amblyopic Eye Visual Acuity Cumulative Distribution N=176 >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

  28. 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

  29. Amblyopia Treatment StudyATS 2A, 2B, 2C AN EVALUATION OF PATCHING REGIMENS ATS2

  30. 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

  31. 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

  32. 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

  33. Study Design Severe Amblyopia Trial 20/100-20/400 Moderate Amblyopia Trial 20/40-20/80 Randomize Randomize Minimal-time patching 2 hrs per day Part-time patching 6 hrs per day Full-time patching all or all but 1 hr per day Part-time patching 6 hrs per day Visit A: 5 ± 1 week Visual acuity testing both eyes Ocular alignment assessment Amblyopia Treatment Index Visit B: 17 ± 1 week Visual acuity testing (masked) both eyes Ocular alignment assessment Stereoacuity Testing ATS2

  34. 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

  35. 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

  36. Patient Characteristics N=189 ATS2B

  37. Patients Randomized N=189 2 Hour Group n=95 6 Hour Group n=94 4-MONTH MASKED EXAM Completed n=92 (97%) Completed n=89 (95%) Patient Follow Up ATS2B

  38. Amblyopic Eye Acuity at 4 Months ATS2B

  39. Amblyopic Eye Mean Acuity at Each Visit Baseline 5 Weeks 4 Months 20/32 20/32-2 20/32-2 20/40+ 20/40+ 20/40 20/50 Mean Visual Acuity Score 20/63+ 20/63+ 20/63 20/80 2 Hours N=95 2 Hours N=92 2 Hours N=87 6 Hours N=94 6 Hours N=89 6 Hours N=85 ATS2B

  40. 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 6-hour group was worse. • Median Score • Subscale2 Hours6 Hours • Adverse Effects 2.13 2.13 • Difficulty with Compliance 2.33 2.33 • Social Stigma 2.67 3.00 ATS2B

  41. 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

  42. 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

  43. 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

  44. 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

  45. Patient Characteristics N= 175 ATS2A

  46. Patients Randomized N=175 6 Hour Group n=85 Full-time Group n=90 4-MONTH MASKED EXAM Completed n=73 (86%) Completed n=84 (93%) Patient Follow Up ATS2A

  47. Amblyopic Eye Acuity at 4 Months ATS2A

  48. Amblyopic Eye Mean Acuity at Each Visit Baseline Exam Five-week Exam Four-month Exam 20/040 20/050 20/50 20/50-2 20/063 20/63-2 20/63-2 20/080 20/100 Mean Visual Acuity Score 20/125 20/160+1 20/160 20/160 20/200 20/250 Six-hrs N=85 Full-time N=90 Six-hrs N=75 Full-time N=77 Six- hrs N=73 Full-time N=84 ATS2A

  49. 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

  50. 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 • Median Score • Subscale6 HoursFull-Time • Adverse Effects 2.25 2.50 • Difficulty with Compliance 2.33 2.42 • Social Stigma 3.00 3.00 ATS2A

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