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2018 pedig amblyopia v1

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2018 pedig amblyopia v1

  1. 1. Amblyopia Treatment Studies Pediatric Eye Disease Investigator Group 2002-2018 (Based on Publications as of September 2018) Alvina Pauline D. Santiago, MD September 2018 #PEDIG (c) APSantiago 2018
  2. 2. http://pedig.jaeb.org/Studies.aspx http://www.abcd-vision.org/amblyopia/ats-pedig.html #PEDIG(c) APSantiago 2018 http://talleyeyecare.com
  3. 3. Amblyopia Definition Gunter K von Noorden • Unilateral or bilateral decrease in VA • caused by pattern vision deprivation (lack of adequate vision stimulation) or abnormal binocular interaction • no cause can be detected by physical examination • reversible by therapeutic measures http://www.ascrs.org vonNoorden GK. Amblyopia. A Multidisciplinary Approach. Proctor Lecture. IOVS; 1985; 26: 1704-16 #PEDIG (c) APSantiago 2018
  4. 4. Definition of Terms: PEDIG •Amblyopia • Mild: 20/25 to < 20/40 • Moderate: 20/40 to 20/100 ATS-1, -8, -9 20/40 to 20/80 ATS-2B, -4, 10 • Severe: 20/100 to 20/400 ATS-2A #PEDIG (c) APSantiago 2018
  5. 5. 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 VIII. Arch Ophthalmol 2002: 120(3) 268-278 #PEDIG (c) APSantiago 2018
  6. 6. Amblyopia Treatment Study-1 (ATS-01) Atropine vs part-time patch, moderate amblyopia  3-7 years  >/= 3 lines 79%P, 74%A  Atropine better acceptability  Strabismic=anisometropic amblyopia  2 yr follow-up, after 6 months treatment, both 2 lines behind  Same rates of deterioration & improvement  New strabismus resolved with cessation of treatment (18%P, 16%A) #PEDIG (c) APSantiago 2018
  7. 7. 10 & 15 years follow-up • improvement maintained • residual amblyopia common http://www.ibeta.com Arch Ophthalmol 2008: 1039-1044; JAMA Ophthalmol. 2014 July ; 132(7): 799–805 Amblyopia Treatment Study-1 (ATS-01) Atropine vs part-time patch, moderate amblyopia http://logopond.com/ #PEDIG (c) APSantiago 2018
  8. 8. 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 https://upload.wikimedia.org https://www.hosteurope.de https://blog.logos.com #PEDIG (c) APSantiago 2018
  9. 9. Amblyopia Treatment Study-2A (ATS-2A) Patch 6 hrs vs full time, severe amblyopia • 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 http://oceansignal.com http://oceansignal.com Ophthalmology 2003: 110(11) 2075-2087 #PEDIG (c) APSantiago 2018
  10. 10. Amblyopia Treatment Study-2B (ATS-2B) Patch 2 hrs (minimal time) vs 6 hrs (part time) for Moderate amblyopia • 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 https://www.hosteurope.de https://upload.wikimedia.org http://oceansignal.com Arch Ophthalmol 2003: 121 (5) 603-611 #PEDIG (c) APSantiago 2018
  11. 11. Amblyopia Treatment Study-2C (ATS-2C) Recurrence after cessation of patching / Atropine • 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-weaning J AAPOS 2004: 8(5): 420-428 #PEDIG (c) APSantiago 2018
  12. 12. 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 http://cdn4.teen.com http://cdn4.teen.com #PEDIG (c) APSantiago 2018
  13. 13. 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 http://cdn4.teen.com Arch Ophthalmol 2005: 123: 437-477 (Control) Am J Ophthalmol 2004: 137: 581-583 (10-18yrs) Arch Ophthalmol 2007: 125: 655-659 #PEDIG (c) APSantiago 2018
  14. 14. Amblyopia Treatment Study-3 (ATS-3) 7 to < 18: spectacles vs atropine/patch • Responders: improved > 10 letters / 2 lines • Improves with glasses 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 http://cdn4.teen.com Arch Ophthalmol 2005: 123: 437-477 (Control) Am J Ophthalmol 2004: 137: 581-583 (10-18yrs) Arch Ophthalmol 2007: 125: 655-659 #PEDIG (c) APSantiago 2018
  15. 15. Amblyopia Treatment Study-4 (ATS-4) Atropine weekend vs daily; moderate amblyopia • 20/40-20/80 • ages 3-7 years • Similar results with weekend atropine vs daily atropine • 2.3 lines in both groups https://thejobshop.files.wordpress.com Ophthalmology 2004: 111: 2076-2085 #PEDIG (c) APSantiago 2018
  16. 16. Amblyopia Treatment Study-5 (ATS-5) 3 to < 7y, spectacles alone • amblyopia improved with glasses by > 2 lines in 77% • amblyopia resolved in 27% with glasses alone • 3 line improvement average • Lessen the burden of amblyopia therapy Ophthalmology 2006: 113 (6) 895-903. #PEDIG (c) APSantiago 2018
  17. 17. Amblyopia Treatment Study-5 (ATS-5) spectacles first then patch 2 hrs vs spectacles, 20/40-20/400 o Strabismic &anisometropic amblyopia o 2 hrs (1 hr near activity) + specs vs. specs alone • At 5 wks: 1.1 lines improvement for treated; 0.5 lines for specs alone • 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 https://t2.ftcdn.net ✚ http://cdn4.teen.com #PEDIG (c) APSantiago 2018 http://cdn4.teen.com
  18. 18. Amblyopia Treatment Study-6 (ATS-6) 3 to <7, patch 2 hrs with near vs far activities after spectacles • 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) http://www.adventuresetup.com http://glacialblog.com J AAPOS 2005: 9: 129-136 #PEDIG (c) APSantiago 2018
  19. 19. 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) • 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 Ophthalmology 2008; 115: 2071-78 #PEDIG (c) APSantiago 2018
  20. 20. 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) • 3.6 lines improvement in severe amblyopic group • Adding near activities did 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 Ophthalmology 2008; 115: 2071-78 #PEDIG (c) APSantiago 2018
  21. 21. Amblyopia Treatment Study-7 (ATS-7) Bilateral refractive amblyopia 20/40-20/400; specs x 1 yr (Response to treatment of previously untreated presumed bilateral refractive amblyopia) • less than 10 years old • Hypermetropia > 4.0D; • astigmatism > 2.0D • Eyeglasses alone improves binocular VA to 20/25 or better within 1 year http://cdn4.teen.com Am J Ophthalmol 2007: 144: 487-496 #PEDIG (c) APSantiago 2018
  22. 22. • Age 7-12; moderate amblyopia 20/40-20/100 • similar degrees of improvement • About 1 in 5 achieved VA of 20/25 or better in the amblyopic eye. • Atropine and patching achieved similar results among older children with unilateral amblyopia Amblyopia Treatment Study-9 (ATS-9) (7 to <13, ATS-1: weekend atropine vs. patch 2hours http://dissurat.net https://t2.ftcdn.net Arch Ophthalmol. 2008;126(12):1634-1642 #PEDIG (c) APSantiago 2018
  23. 23. Amblyopia Treatment Study-10 (ATS-10) Bangerter filters vs. patching • moderate amblyopia 20/40-20/80; 3-<10y. • At 24 wks, 1.9 lines improvement with Bangerter, vs.2.3 lines in patching group • Average difference in vision improvement between Bangerter filters and patching was less than half a line • ower burden of treatment on the child and family, Bangerter filter treatment is a reasonable option to consider for initial treatment of moderate amblyopia. Ophthalmology 2010;117:998-1004. | #PEDIG (c) APSantiago 2018 23
  24. 24. ATS 13: An Observational Study of Optical Correction for Strabismic & Combined Strabismic Anisometropic Amblyopia in Children 3 to < 7 years old • VA after 18 weeks improved mean of 2.6 lines • 75% > 2 lines, 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 improvement; • may consider as primary sole initial treatment Ophthalmology 2012; 119: 150-158. Epub 2011 Sep 29. #PEDIG (c) APSantiago 2018
  25. 25. ATS 15: Increasing patching for amblyopia study from 2 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 #PEDIG (c) APSantiago 2018
  26. 26. Amblyopia Treatment Study-17 (ATS- 17) Levodopa for Residual Amblyopia • 7-12y, 20/50 to 20/400 with patching • 139 children 7-12 years old • Strabismic &/or anisometropic amblyopia • Pilot showed improvement at 4 weeks • But study at 18 weeks: placebo = levodopa Ophthalmology. 2015 May;122(5):874-819 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. #PEDIG (c) APSantiago 2018
  27. 27. What more PEDIG? http://www.imore.com http://www.geek.com http://www.cclonline.com/ http://icons.iconarchive.com #PEDIG (c) APSantiago 2018
  28. 28. Amblyopia Treatment Study-18 (ATS-18) Binocular Computer Studies for Amblyopia Ended May 2016 • 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. #PEDIG (c) APSantiago 2018
  29. 29. Amblyopia Treatment Study-18 (ATS-18) Binocular iPAD game vs patching (5-12) • Non inferiority RCT • 16 wk trial • iPAD improved 1.05 lines vs patching 1.35 lines • primary noninferiority analysis was indeterminate • a post hoc analysis suggested that VA improvement with iPad not as good as with 2 hours of prescribed daily patching. Holmes et al … PEDIG. Effect of a binocular iPad game versus part-time patching in children aged 5 to 12 with amblyopia: a randomized clinical trial. JAMA Ophthalmol 2016;134(12) #PEDIG (c) APSantiago 2018
  30. 30. Amblyopia Treatment Study-18 (ATS-18) Binocular iPAD game vs patching (13 to <17) • Amblyopia 20/40 to 20/200 • 16 wks of iPAD 1 h game or patching 2h/day • 3.5 letters in iPAD group vs. 6.5 letters in patching group • Even in the iPAD group, only 13% of patients completed >75% of prescribed treatment • PATCHING still better, iPAD possibly worse • Compliance vs lack of treatment effect? Manh VM, Holmes JM, Lazar EL, et al and Pediatric Eye Disease Investigator Group. A Randomized Trial Of A Binocular iPad Game Versus Part-Time Patching In Children 13 To 16 Years Of Age With Amblyopia. Am J Ophthalmol 2018;186:104-15. #PEDIG (c) APSantiago 2018
  31. 31. Non PEDIG RCTs https://www.aao.org #PEDIG (c) APSantiago 2018
  32. 32. Non PEDIG RCTs https://www.aao.org • 3-8 y, 20/40 to 20/100 • Glasses x 12 wks, no improvement • Occluded 50% x 4h vs Patching 2h • Not inferior to patching • Alternative for treatment #PEDIG (c) APSantiago 2018
  33. 33. Amblyopia Treatment Study-19 (ATS-19) Excimer Laser Surgery for Anisometropic Amblyopia • Upcoming • To compare the efficacy and safety of surgical treatment (PRK) versus non-surgical treatment of anisometropic amblyopia in children who have failed conventional treatment due to non- compliance or non-response. #PEDIG (c) APSantiago 2018
  34. 34. Amblyopia Treatment Study-20 (ATS-20) Binocular Dig Rush Game for Amblyopia • Recruiting • 1 hour/day of binocular game play 5 days per week plus spectacle correction vs. spectacle correction only • for treatment of amblyopia • children 4 to <13 years of age. #PEDIG (c) APSantiago 2018 https://www.ophth.wisc.edu/blog/2018/02/12/binocular-dig- rush-game-treatment-amblyopia/
  35. 35. Recap: Lessons learned from PEDIG 1. Atropine = patching • 3-7 years old, 20-40 to 20/100 • Anisometropic and strabismic amblyopia • Long-term follow-up 10y and 15y same • New strabismus can develop in either by 2 years 16-18%, • Resolved at cessation of therapy • Residual amblyopia common • 7-12y, 20/40 to 20/100 • 1 in 5 achieved > 20/25 #PEDIG (c) APSantiago 2018
  36. 36. Recap: Lessons learned from PEDIG 2. 6 hours = full time • 3-7 years old • Severe amblyopia 20/100-20/400 3. 2 = 6 hours • 3-7 years old • Moderate amblyopia 20/40 to 20/80 #PEDIG (c) APSantiago 2018
  37. 37. Recap: Lessons learned from PEDIG 4. Amblyopia improves with glasses alone. • 20/40 to 20/400, 7-17y (25%) • 3 to <7, 20/40 to 20/400 • Resolved in 27% • Improved in 77% • Better improvement in strabismic than combined strabismic and amblyopic amblyopia • Less than 10y, 20/40 to 20/400 • Bilateral refractive amblyopia VA > 20/25 in a year AP Santiago MD 2017 #PEDIG (c) APSantiago 2018
  38. 38. Recap: Lessons learned from PEDIG 5. Atropine and/or patching can be added after glasses. • Moderate to severe amblyopia 20/40 to 20/400, 7 to <18 6. Add patching after glasses given time to work. • Moderate to severe amblyopia: 20/40 to 20/400 • 3 to <7y, 2h patch (1 hr near) • 7-12 even if previously treated • 13 to <18 if no previous treatment #PEDIG (c) APSantiago 2018
  39. 39. Recap: Lessons learned from PEDIG 7. Daily = weekly atropine • 3-7 years • Moderate amblyopia: 20/40 to 20/80 8. Near = Far • 3-7 years • moderate to severe amblyopia: 20/40 to 20/400 AP Santiago MD 2017 #PEDIG (c) APSantiago 2018
  40. 40. Lessons learned from PEDIG Studies 9. Severe amblyopia can improve even with 2 h of patching • 3-7 years, 20/40 to 20/400 10.Bangerter filter a reasonable option. • 3 to <10, 20/40 to 20/80 • Not better than patching • More acceptable 11.Patching 2h/d better than binocular iPAD • 5-<13, 13 to <17 • 20/40 to 20/200 #PEDIG (c) APSantiago 2018
  41. 41. Lessons learned from PEDIG Studies 12. Intensive final push with atropine and patch not effective. 13.Levodopa same as placebo. • 8-17y, already on patching 14.6h >2h: Increasing 2 to 6 hours can improve amblyopia • 3 to <8m 20/50 to 20/400 • if plateau with 2 hours reached 15.Plano lenses don’t work. 16.Standardizing vision therapy unsuccessful. #PEDIG (c) APSantiago 2018
  42. 42. What the future holds • Laser refractive correction as a viable option for anisometropic amblyopia • Others options • Virtual reality games • Smart glasses • Dichoptic movie viewing AP Santiago MD 2017 #PEDIG (c) APSantiago 2018
  43. 43. Virtual Reality Games for Amblyopia ❖ 0:33 The Oculus Rift ❖ 0.38 – 1:29 How it Works https://www.youtube.com/watch?v=KumScsJ0xNQ #PEDIG (c) APSantiago 2018
  44. 44. Amblyopia Glasses VIDI SMART GLASSES AMBLYZ AMBLYOPIA GLASSES http://eyepatch.com.au/product/Vidi-Smart-Glasses https://www.aao.org #PEDIG (c) APSantiago 2018
  45. 45. Every closed eye is not sleeping, and every open eye is not seeing. -- Bill Cosby #PEDIG(c) APSantiago 2018

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