2015 PEDIG Amblyopia Treatment Studies

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Information about 2015 PEDIG Amblyopia Treatment Studies

Published on September 14, 2015

Author: AlvinaPaulineSantiag

Source: slideshare.net

1. Amblyopia Treatment Studies Pediatric Eye Disease Investigator Group 2002-2015 (Publications as of September 1, 2015) Alvina Pauline D. Santiago, MD September 2015

2. http://pedig.jaeb.org/Studies.aspx http://www.abcd-vision.org/amblyopia/ats-pedig.html AP Santiago MD 2015

3. Amblyopia Treatment Study-1 (ATS-01) Atropine vs part-time patch, moderate amblyopia I. Arch Ophthalmol 2002: 120(3) 268-278 II. Arch Ophthalmol 2002: 120 (3) 281-287 III. Arch Ophthalmol 2003: 121 (11): 1625- 32 IV. Arch Ophthalmol 2005: 123 (2): 149-157 V. J AAPOS 2005: 9 (6): 542-545 VI. Arch Ophthalmol 2008: 1039-1044 VII. JAMA Ophthalmol. 2014 July ; 132(7): 799–805 AP Santiago MD 2015

4. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia I. Arch Ophthalmol 2002: 120(3) 268-278 VA 20/40-20/100 3 or more lines: Atropine (74%) & Patching (79%) Atropine & patching similar for age 3-7 yr Atropine better acceptability AP Santiago MD 2015

5. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia II. Arch Ophthalmol 2002: 120 (3) 281-287 Clinical profile of moderate amblyopia subjects moderate amblyopia 20/40-20/100 7 yrs and below Same effect for strabismic and anisometropic amblyopia AP Santiago MD 2015

6. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia III. Arch Ophthalmol 2003: 121 (11): 1625-32 Impact of patching vs atropine Both well tolerated by child and family Atropine more favorable AP Santiago MD 2015

7. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia IV. Arch Ophthalmol 2005: 123 (2): 149-157 2 yr follow up after 6 month of patching or atropine Similar results in both groups Amblyopic eye still 2 lines worse than sound eye AP Santiago MD 2015

8. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia V. J AAPOS 2005: 9 (6): 542-545 Effect of amblyopia tx on ocular alignment Same rates of deterioration or improvement in both groups New strabismus by 2 yrs: most resolved after cessation of treatment 18% in patching: 2 greater than 8PD 16% in atropine: 3 greater than 8PD AP Santiago MD 2015

9. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia VI. Arch Ophthalmol 2008: 1039-1044 10 year follow up improvement of amblyopia maintained Outcome similar for both groups residual amblyopia common treatment initiated at AP Santiago MD 2015 http://www.ibeta.com

10. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia VII. JAMA Ophthalmol. 2014 July ; 132(7): 799– 805 15 year follow up improvement of amblyopia maintained Outcome similar for both groups Mild residual amblyopia common treatment initiated at age 3-7 years AP Santiago MD 2015 http://logopond.com/

11. Amblyopia Treatment Study-2 (ATS-2) (6h vs full; 2h vs 6h) I. Ophthalmology 2003: 110(11) 2075-2087 II. Arch Ophthalmol 2003: 121 (5) 603-611 III. J AAPOS 2004: 8(5): 420-428 AP Santiago MD 2015 https://www.hosteurope.de https://upload.wikimedia.org https://blog.logos.com

12. Amblyopia Treatment Study-2A (ATS- 2A) Patch 6 hrs vs full time, severe amblyopia I. Ophthalmology 2003: 110(11) 2075-2087 Full time: all waking hrs minus 1 hour off Severe amblyopia: 20/100-20/400 Age 3-7 years After 4 months 4.8 lines in 6 hrs group; vs 4.7 in full time AP Santiago MD 2015 http://oceansignal.com http://oceansignal.com

13. Amblyopia Treatment Study-2B (ATS- 2B) Patch 2 hrs (minimal time) vs 6 hrs (part time) for Moderate amblyopia II. Arch Ophthalmol 2003: 121 (5) 603-611 moderate: 20/40-20/80 ages 3-7 years At 4 months: 2.4 lines in both groups with 1 hr of near visual activity AP Santiago MD 2015 https://www.hosteurope.de https://upload.wikimedia.org http://oceansignal.com

14. Amblyopia Treatment Study-2C (ATS-2C) Recurrence after cessation of patching / Atropine III. J AAPOS 2004: 8(5): 420- 428 younger than age 8 3 months of amblyopia treatment Recurrence same 24% of patched patients; 21% of atropinized 1/4 experience recurrence within 1st year of cessation RCT for weaning vs. no- AP Santiago MD 2015

15. Amblyopia Treatment Study-3 (ATS-3) 7 to < 18: spectacles vs atropine/patch Arch Ophthalmol 2005: 123: 437-477 (Control) Am J Ophthalmol 2004: 137: 581-583 (10-18yrs) Arch Ophthalmol 2007: 125: 655-659 AP Santiago MD 2015 http://cdn4.teen.com

16. Amblyopia Treatment Study-3 (ATS-3) 7 to < 18: spectacles vs atropine/patch ages 7-17 years 20/40-20/400 Given optimal optical correction then randomized Tx: glasses, patch plus near activity, atropine No Tx: glasses alone AP Santiago MD 2015 http://cdn4.teen.com

17. Amblyopia Treatment Study-3 (ATS-3) 7 to < 18: spectacles vs atropine/patch Responders: improved by >/= 10 letters / 2 lines Amblyopia improves with Rx alone in 25% Most patients left with residual VA deficit Ages 7-12: tx improved amblyopia even if previously treated Ages 13-17: tx improved if no previous tx for amblyopia Unknown: if treatment results robust (if it will stay) AP Santiago MD 2015 http://cdn4.teen.com

18. Amblyopia Treatment Study-4 (ATS-4) Atropine weekend vs daily; moderate amblyopia Ophthalmology 2004: 111: 2076-2085 20/40-20/80 ages 3-7 years Similar results with weekend atropine vs daily atropine 2.3 lines in both groups AP Santiago MD 2015 https://thejobshop.files.wordpress.com

19. Amblyopia Treatment Study-5 (ATS-5) 3 to < 7, spectacles alone vs patch 2 hrs + spectacles Ophthalmology 2006: 113 (6) 895- 903. amblyopia improved with Rx by >/= 2 lines in 77% amblyopia resolved in 27% with Rx alone 3 line improvement average Lessen the burden of amblyopia therapy AP Santiago MD 2015

20. Amblyopia Treatment Study-5 (ATS-5) 3 to <7, spectacles alone, then patch 2 hrs vs spectacles Ophthalmology 2006: 113 (6) 904-912. • Strabismic and anisometropic amblyopia • 20/40-20/400 • 2 hrs (1 hr near activity) + specs vs. specs alone AP Santiago MD 2015

21. Amblyopia Treatment Study-5 (ATS-5) spectacles alone, then patch 2 hrs vs spectacles Ophthalmology 2006: 113 (6) 904-912. 5 wks: 1.1 lines treated; 0.5 lines specs Any visit average: 2.2 lines treated; 1.1 lines specs After glasses, 2 hrs patching (with 1 hr near activity) improves moderate to severe amblyopia AP Santiago MD 2015 https://t2.ftcdn.net ✚http://cdn4.teen.com

22. Amblyopia Treatment Study-6 (ATS-6) 3 to <7, patch 2 hrs with near vs far activities after spectacles J AAPOS 2005: 9: 129-136 Pilot: 4 wks: suggestion of greater improvement in amblyopic eye with near activities prescribed 2.6 lines near; 1.6 lines far (p=0.07) AP Santiago MD 2015 http://www.adventuresetup.com http://glacialblog.com

23. Amblyopia Treatment Study-6 (ATS-6) 3 to <7, patch 2 hrs with near vs far activities after spectacles (VA 20/40 to 20/400) AP Santiago MD 2015 Ophthalmology 2008; 115: 2071- 78 At 8 wks: improvement in amblyopic eye Distance activity: 2.6 lines Near activity: 2.5 lines 2.6 lines near; 1.6 lines far (p=0.07) Similar for both groups, even at 2, 5, 17 wks. http://s7.photobucket.com

24. Amblyopia Treatment Study-6 (ATS-6) 3 to <7, patch 2 hrs with near vs far activities after spectacles (VA 20/40 to 20/400) AP Santiago MD 2015 Ophthalmology 2008; 115: 2071-78 3.6 lines improvement in severe amblyopic group Near activities do not improve VA outcome in anisometropic, strabismic, combined amblyopia with 2 hrs of daily patching Severe amblyopia can respond even to 2 hrs of daily patching http://www.getbettergradesnow.com

25. Amblyopia Treatment Study-7 (ATS-7) Bilateral refractive amblyopia; specs x 1 yr (Response to treatment of previously untreated presumed bilateral refractive amblyopia) Am J Ophthalmol 2007: 144: 487-496 20/40-20/400 less than 10 years Hypermetropia >/= 4.0D; astigmatism >/= 2.0D Eyeglasses alone improves binocular VA to 20/25 or better within 1 year AP Santiago MD 2015 http://cdn4.teen.com

26. Amblyopia Treatment Study-8 (ATS-8) 3 to <7, atropine vs Atropine plus plano lens to sound eye Arch Ophthalmol 2009;127(1):22-30 Moderate amblyopia .20/40-20/100 Weekend atropine plus plano lens = atropine alone AP Santiago MD 2015 http://dissurat.net

27. Amblyopia Treatment Study-9 (ATS-9) (7 to <13, ATS-1: weekend atropine vs. patch 2hours Arch Ophthalmol. 2008;126(12):1634-1642 Age 7-12; moderate amblyopia 20/40- 20/100 Treatment with atropine or patching led to similar degrees of improvement among 7- to 12-year-olds with moderate amblyopia. About 1 in 5 achieved visual acuity of 20/25 or better in the amblyopic eye. Atropine and patching achieve similar results among older children with unilateral amblyopia AP Santiago MD 2015 http://dissurat.net https://t2.ftcdn.net

28. Amblyopia Treatment Study-10 (ATS-10) Bangerter filters vs. patching Ophthalmology 2010;117:998-1004. | moderate amblyopia 20/40-20/80; 3-<10y. At 24 wks, 1.9 lines improvement with Bangerter, vs.2.3 lines in patching group Because the average difference in visual acuity improvement between Bangerter filters and patching was less than half a line, and there was lower burden of treatment on the child and family, Bangerter filter treatment is a reasonable option to consider for initial treatment of moderate amblyopia. AP Santiago MD 2015

29. ATS 11: A randomized trial to evaluate combined patching-atropine treatment for residual amblyopia Evaluate effectiveness of treatment of residual amblyopia in 3-10y VA 20/32 to 20/63 (mild residual amblyopia) RCT: intensive treatment vs. rapid weaning plus glasses Intensive: (42 hrs weekly dose plus daily atropine) Pediatric Eye Disease Investigator Group. Randomized trial to evaluate combined patching and atropine for residual amblyopia. Arch Ophthalmol 2011;129(7):960-2. AP Santiago MD 2015

30. http://www.clipartbest.com ATS 11: A randomized trial to evaluate combined patching-atropine treatment for residual amblyopia Intensive final push of combined treatment with patching and daily atropine did not produce a better visual acuity outcome after 10 weeks Compared with a control group in whom treatment was gradually discontinued AP Santiago MD 2015

31. http://www.clipartbest.com ATS 11: A randomized trial to evaluate combined patching-atropine treatment for residual amblyopia The study was stopped on recommendation of the data and safety monitoring committee slow recruitment conditional power analysis indicating that the study was unlikely to find a statistically significant benefit AP Santiago MD 2015

32. ATS 12: A randomized trial comparing patching with active vision therapy to patching with control vision therapy as treatment for amblyopia in children 7 to < 13 years old Lyon DW, Hopkins K, Chu RH et al. Feasibility of a clinical trial of vision therapy for treatment of amblyopia. Optom Vis Sci 2013; 90(5): 475-481. 16 week vision therapy feasible Standardizing approach to vision therapy not successful AP Santiago MD 2015http://alderwoodvisiontherapy.com

33. ATS 13: An Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to < 7 years old Optical Treatment of Strabismic and Combined Strabismic Anisometropic Amblyopia. Ophthalmology 2012; 119: 150-158. Epub 2011 Sep 29. VA after 18 weeks improved mean of 2.6 lines 75% >/= 2 line, 54% >/= 3 lines Resolution of amblyopia in 32% Greater in Strabismic Amblyopia alone (3.2 vs 2.3 lines) VA improved regardless of whether alignment better Optical treatment alone results in clinically meaningful AP Santiago MD 2015

34. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old Repka MX, Kraker RT, Beck RW, et. al., Pediatric Eye Disease Investigator Group. Pilot study of levodopa dose as treatment for residual amblyopia in children aged 8 years to younger than 18 years. Arch Ophthalmol 2010;128(9):1215-7. AP Santiago MD 2015 https://encrypted-tbn1.gstatic.com

35. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old At the time of enrollment, subjects were required to have been treated with at least 2 hours per day of daily patching And stable visual acuity defined as less than 5 letters or one logMAR line of improvement since a previous visit at least 8 weeks earlier. AP Santiago MD 2015 https://www.hosteurope.de

36. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old Intervention: continuing 2 hours of daily patching addition of levodopa in one of two doses randomly assigned with equal probability (0.51 or 0.76 mg/kg/tid, referred to as lower dose and higher dose, respectively). AP Santiago MD 2015 https://www.hosteurope.de✚ LEVODOPA + CARBIDOPA

37. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old Intervention: The study medication was administered for 8 weeks with one additional week for tapering of treatment. Levodopa was prepared in capsules combined with carbidopa 0.17 mg/kg/tid. Carbidopa was combined with levodopa to reduce side-effects associated with levodopa alone. AP Santiago MD 2015

38. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old The mean improvement in amblyopic eye in 9-week primary outcome visit was +4 (±4) letters in the 16 subjects in the lower dose group and +6 (±6) letters in the 17 subjects in the higher dose group AP Santiago MD 2015

39. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old An improvement of 10 or more letters noted in 2 (13%) in low dose, and 5 (29%) in high dose group at 9 wks Fellow eye improved 1 letter in high dose and zero letter is low dose group Justification: Small sample, experience with drug, promising result AP Santiago MD 2015

40. ATS 15: Increasing patching for amblyopia study from 2 hours to 6 hours (3 to <8, 20/50 to 20/400) When amblyopic eye VA stops improving with 2 hours of daily patching, increasing the daily patching dosage to 6 hours results in more improvement in VA after 10 weeks compared with continuing 2 hours daily. Pediatric Eye Disease Investigator Group. A randomized trial of increasing patching for amblyopia. Ophthalmology 2013 Nov;120(11):2270-7. Epub 2013 Jun 4 AP Santiago MD 2015

41. David K. Wallace, MD, MPH1; Elizabeth L. Lazar, MSPH2; Earl R. Crouch III, MD3; Darren L. Hoover, MD4; Raymond T. Kraker, MSPH2; Susanna M. Tamkins, OD; for the Pediatric Eye Disease Investigator Group. Time course and predictors of amblyopia improvement with 2 hours of daily patching. JAMA Ophthalmol. 2015;133(5):606-609. doi:10.1001/jamaophthalmol.2015.6. AP Santiago MD 2015 ATS 15: Increasing patching for amblyopia study from 2 hours to 6 hours (3 to <8, 20/50 to 20/400)

42. ATS 16: Augmenting atropine treatment for amblyopia with plano lens to sound eye 3 to <8, 20/50 to 20/400 Objective: evaluate the effectiveness of adding a plano lens to weekend atropine in patients with amblyopia still present after visual acuity has stabilized with initial treatment. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. AP Santiago MD 2015

43. Objective: evaluate the effectiveness of adding a plano lens to weekend atropine in patients with amblyopia still present after visual acuity has stabilized with initial treatment. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. AP Santiago MD 2015 J AAPOS 2015;19:42-48 ATS 16: Augmenting atropine treatment for amblyopia with plano lens to sound eye 3 to <8, 20/50 to 20/400

44. Results: atropine + plano lens = atropine only 1.1 vs 0.6, not statistically significant Conclusion: Small benefit to adding plano lens Larger study recommended AP Santiago MD 2015 J AAPOS 2015;19:42-48 ATS 16: Augmenting atropine treatment for amblyopia with plano lens to sound eye 3 to <8, 20/50 to 20/400

45. Amblyopia Treatment Study-17 (ATS-17) Levodopa for Residual Amblyopia Ophthalmology. 2015 May;122(5):874-819 Objective: efficacy and short term safety of levopopa as adjunctive treatment to amblyopia 139 children 7-12 years old Strabismic &/or anisometropic amblyopia Residual 20/50-20/400 with patching AP Santiago MD 2015

46. Amblyopia Treatment Study-17 (ATS- 17) Levodopa for Residual Amblyopia Intervention: 16 weeks while patching 2h/d oral levodopa (oral levodopa 0.76 mg/kg with carbidopa 0.17 mg/kg ) vs placebo TID Results: at 18 weeks Levodopa = placebo (5.2 vs 3.8 letters=not statistically significant) No adverse effect from levodopa AP Santiago MD 2015

47. What more PEDIG? http://www.imore.com http://www.geek.com http://www.cclonline.com/ http://icons.iconarchive.com AP Santiago MD 2015

48. Amblyopia Treatment Study-18 (ATS- 18) Binocular Computer Activities for Treatment of Amblyopia REVIEW of LITERATURE Li J, Thompson B, Deng D, Chan LY, Yu M, Hess RF. Dichoptic training enables the adult 1080 amblyopic brain to learn. Curr Biol 2013;23:R308-9. 1081 Hess RF, Thompson B, Black JM, et al. An iPod treatment of amblyopia: an updated 1082 binocular approach. Optometry 2012;83:87-94. 1083 To L, Thompson B, Blum JR, Maehara G, Hess RF, Cooperstock JR. A game platform for 1084 treatment of amblyopia. IEEE Trans Neural Syst Rehabil Eng 2011;19:280-9. 1085 Li SL, Jost RM, Morale SE, et al. A binocular iPad treatment for amblyopic children. Eye (2014) 28, 1246–1253; doi:10.1038/eye.2014.165; published online 25 July 2014. Li SL, Jost RM, Morale SE, et al. Binocular iPad Treatment of Amblyopia for Lasting Improvement of Visual Acuity. JAMA Ophthalmol. 2015;133(4):479-480. doi:10.1001/jamaophthalmol.2014.5515. Birch EE, Li S, Jost RM, et al. Binocular iPad treatment for amblyopia in preschool 1088 children. J AAPOS 2014 AAPOS. 1089 AP Santiago MD 2015

49. Amblyopia Treatment Study-18 (ATS- 18) Binocular Computer Activities for Treatment of Amblyopia Recruiting as of August 31, 2015 To compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4 days per week) with 2 hours/day of patching 7 days per week, in children 5 to <13 years of age (younger cohort), as a non- inferiority study. To compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4 days per week) with 2 hours/day of patching 7 days per week, in children 13 to <17 years of age (older cohort), as a superiority study. AP Santiago MD 2015

50. Lessons learned from PEDIG Studies 1. Atropine = patching 2. 6 hours = full time 3. 2 = 6 hours 4. Amblyopia improves with glasses alone. 5. Add patching after glasses given time to work. AP Santiago MD 2015

51. Lessons learned from PEDIG Studies 6. Spectacles and patching even for 13-17. 7. Daily = weekly 8. Near = Far 9. Severe amblyopia can improve even with 2 h of patching 10. Bangerter filter = patching AP Santiago MD 2015

52. Lessons learned from PEDIG Studies 11. Intensive final push with atropine and patch not effective. 12. Levodopa promising but same as placebo. 13. 6h >2h: Increasing 2 to 6 hours can improve amblyopia (if plateau with 2 hours reached). 14. Plano lenses don’t work. AP Santiago MD 2015

53. Every closed eye is not sleeping, and every open eye is not seeing. -- Bill Cosby

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