Patching vs Atropine to Treat Amblyopia in Children Aged 7 to 12 Years (original) (raw)

Abstract

Objective-To compare patching with atropine eye drops in the treatment of moderate amblyopia (20/40-20/100) in children age 7 to 12 years. Methods-In a randomized multi-center clinical trial, 193 children with amblyopia were randomized to weekend atropine or patching 2 hours per day of the sound eye. Main Outcome Measure-Masked assessment of amblyopic eye visual acuity using the EETDRS testing protocol at 17 weeks. Results-At 17 weeks, visual acuity had improved from baseline by an average of 7.6 letters in the atropine group and 8.6 letters in the patching group. The mean difference (patching minus atropine) between groups adjusted for baseline acuity was 1.2 letters (ends of complementary 1-sided 95% confidence intervals for noninferiority =-0.7 and +3.1 letters). Based on the confidence intervals this difference met the pre-specified definition for equivalence (ends of confidence intervals <5 letters). Amblyopic eye visual acuity was 20/25 or better in 15 subjects (17%) in the atropine group and 20 subjects (24%) in the patching group (difference = 7%, 95% confidence interval =-3% to 17%). Conclusions-Treatment with atropine or patching leads to similar degrees of improvement in 7 to 12 year old children with moderate amblyopia. About 1 in 5 achieves 20/25 or better visual acuity in the amblyopic eye. Application to Clinical Practice-Treatment of older children with unilateral amblyopia.

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References (192)

  1. Writing Committee: Lead authors: Mitchell M. Scheiman, OD, Richard W. Hertle, MD, Raymond T. Kraker, MSPH Additional writing committee members (alphabetical): Roy W. Beck MD, PhD, Eileen E. Birch PhD, Joost Felius, PhD, Jonathan M. Holmes BM, BCh, James Kundart, MD, David G. Morrison, MD, Michael X. Repka MD, Susanna M. Tamkins, OD The Pediatric Eye Disease Investigator Group Clinical Sites that Participated in this Protocol Sites are listed in order by number of patients enrolled into the study. Personnel are listed as (I) for Investigator, (C) for Coordinator, and (V) for Visual Acuity Examiner.
  2. Susanna M. Tamkins, (I);
  3. Adam S. Perlman, (I);
  4. Nidia Y. Rosado, (C);
  5. Ana C. Rosa, (C);
  6. Erin X. Goga, (V);
  7. Eva M. Olivares, (C);
  8. Garnet Yokoi, (V);
  9. Lesley L. Bursey, (V);
  10. Candice Robinson, (V);
  11. Effie Lilas, (V);
  12. Gloria Chow, (V);
  13. Mirna Garcia, (V) Erie PA -Pediatric Ophthalmology of Erie (23)
  14. Nicholas A. Sala, (I);
  15. Veda L. Zeto, (C);
  16. Rhonda M. Hodde, (C);
  17. Benjamin H. Whitling, (V);
  18. Cindy E. Tanner, (V) Dallas TX -Pediatric Ophthalmology (16)
  19. David R. Stager, (I);
  20. Mary K. Alters, (C);
  21. Joost Felius, (C);
  22. June M. Gartlir, (V);
  23. Alexia B. Perez, (V) West Des Moines IA -Wolfe Clinic (16)
  24. Donny W. Suh, (I);
  25. Marilee McNeece, (C);
  26. Bethany S Madsen, (C);
  27. Rhonda J. Countryman, (V);
  28. Lisa M Fergus, (V);
  29. Shannon L. Craig, (V);
  30. Ashley D. Andreassen, (V) Cranberry TWP PA -Everett and Hurite Ophthalmic Association (12)
  31. Darren L. Hoover, (I);
  32. Pamela A. Huston, (C);
  33. Jody L. Parker, (V);
  34. Christine J. Deifel, (V);
  35. Barbara R. Fuchs, (V);
  36. Joan M. Addison, (V);
  37. Pamela M. Racan, (V) Fullerton CA -Southern California College of Optometry (
  38. Susan A. Cotter, (I);
  39. Susan M. Shin, (I);
  40. Raymond H. Chu, (I);
  41. Monique M. Nguyen, (I);
  42. Carmen N. Barnhardt, (I);
  43. Erin Song, (I);
  44. Kristine Huang, (I);
  45. Lisa M. Edwards, (I);
  46. Sue M. Parker, (C);
  47. Jamie H Morris, (C);
  48. Rebecca S. Bridgeford, (C) South Charleston WV -Children's Eye Care & Adult Strabismus Sugery (7)
  49. Deborah L. Klimek, (I);
  50. Crystal A. Sigmon, (C);
  51. Lisa L. Winter, (C);
  52. Bounthavy Lisa Greenlee, (V);
  53. Diana K. Brandon, (V) Nashville TN -Vanderbilt Eye Center (6)*
  54. Sean Donahue, (I);
  55. David G. Morrison, (I);
  56. Lori Ann F. Kehler, (I);
  57. Kamila M. Kinder, (C);
  58. Gini B. Taylor-Ward, (C);
  59. Sandy A. Owings, (C);
  60. Neva J. Palmer, (C);
  61. Joseph M. Martin, (V);
  62. Ronald J. Biernacki, (V) Norfolk VA -Eastern Virginia Medical School (6)
  63. Earl R. Crouch, (I);
  64. Eric R. Crouch III, (I);
  65. Gaylord G. Ventura, (C);
  66. Kristen D. Ruark, (V) Birmingham AL -University of Alabama at Birmingham School of Optometry (5)
  67. Robert P. Rutstein, (I);
  68. Wendy L. Marsh-Tootle, (I);
  69. Katherine K. Weise, (I);
  70. Kristine T. Hopkins, (I);
  71. Marcela Frazier, (I);
  72. Cathy H. Baldwin, (C);
  73. Michael P. Hill, (C) Memphis TN -Southern College of Optometry (5)
  74. Kristin K. Anderson, (I);
  75. Erin R. Nosel, (I);
  76. Sean M. Skierczynski, (C);
  77. Christopher W. Lievens, (V);
  78. Hani Ghazi Birry, (V) Boise ID -Intermountain Eye Centers (4)
  79. Katherine A. Lee, (I);
  80. Bonita R. Schweinler, (C);
  81. Larry W. Plum, (V) Chicago IL -Illinois College of Optometry (ICO) (
  82. Yi Pang, (I);
  83. Christine L. Allison, (I);
  84. Sandra S. Block, (I);
  85. Geoffrey W. Goodfellow, (C);
  86. Colleen M. Morrissey, (V) Rockville MD -Stephen R. Glaser, M.D., P.C. (
  87. Stephen R. Glaser, (I);
  88. Allison A. Jensen, (I);
  89. Cera E. Mattingly, (C);
  90. Christen Y. Addison, (C);
  91. Jill R. Mason, (C) Albuquerque NM -Goldblum Family Eye Care Center, P.C. (
  92. Todd A. Goldblum, (I);
  93. Antoinette Ramirez, (C);
  94. Angela Alfaro, (C);
  95. Frances Jaramillo, (V) Colorado Springs CO -The Children's Eye Center (3)
  96. Dave H. Lee, (I);
  97. Nieca D. Caltrider, (I);
  98. Kelly A. Martinez, (C);
  99. Maria M. Busemeyer, (V);
  100. Colleen M. Schwanz, (V) Durham NC -Duke University Eye Center (3)
  101. Laura B. Enyedi, (I);
  102. David K. Wallace, (I);
  103. Sarah K. Jones, (C);
  104. Melinda K. Robinson, (V);
  105. Courtney E. Fuller, (V) Lancaster PA -Family Eye Group (
  106. David I. Silbert, (I);
  107. Noelle S. Matta, (C);
  108. Darlene R. Crick, (N) Wilmington DE -Delaware Vision Academy, L.L.C. (
  109. Don D. Blackburn, (I);
  110. Adam J Wahlig, (C) Anchorage AK -Ophthalmic Associates (2)
  111. Robert W. Arnold, (I);
  112. Mary Diane Armitage, (C);
  113. Nancy H. Brusseau, (V) Grand Rapids MI -Pediatric Ophthalmology, P.C. (
  114. Patrick J. Droste, (I);
  115. Jan Hilbrands, (C);
  116. Jennifer L. Mooney, (V);
  117. Sandra K. Rogers, (V) Pittsburgh PA -Children's Hospital of Pittsburgh (2)
  118. Richard W. Hertle, (I);
  119. Christopher J. King, (C);
  120. Roxanne X. Caterino, (C) Portland OR -Pacific University College of Optometry (2)
  121. Richard London, (I);
  122. James J. Kundart, (I);
  123. Jayne L. Silver, (C);
  124. Garnet M. Yokoi, (V) Rochester MN -Mayo Clinic (2)*
  125. Jonathan M. Holmes, (I);
  126. Brian G. Mohney, (I);
  127. Rebecca A. Nielsen, (C);
  128. Jan M. Sease, (C);
  129. David A. Leske, (C);
  130. Deborah K. Miller, (V);
  131. Virginia Karlsson, (V) Baltimore MD -Wilmer Institute (1)*
  132. Michael X. Repka, (I);
  133. Alex X. Christoff, (C);
  134. Carole R. Goodman, (C);
  135. Xiaonong Liu, (C) Bloomington IN -Indiana School Of Optometry (1)
  136. Don W. Lyon, (I);
  137. Kathryn Gray, (I) Calgary -Alberta Children's Hospital (1)
  138. William F. Astle, (I);
  139. Heather J. Peddie, (C);
  140. Charlene Dawn Gillis, (V) Dallas TX -Pediatric Ophthalmology, P.A. (
  141. Priscilla M. Berry, (I);
  142. Mary K. Alters, (C);
  143. Joost Felius, (C) Durham NC -North Carolina Eye Ear & Throat (1)
  144. Joan Therese Roberts, (I);
  145. Lynelle Gregory Perez, (C);
  146. Marguerite J. Sullivan, (C) Fall River MA -Center for Eye Health Truesdale Clinic (1)
  147. John P. Donahue, (I);
  148. Mary E. Silvia, (C);
  149. Deborah P. Branco, (V) Hershey PA -Penn State University (1)
  150. Marianne E. Boltz, (I);
  151. Penelope J. Nester, (C);
  152. Mary E Wilmarth, (C);
  153. Laura E. Walter, (C) Marlton NJ -Michael F. Gallaway, O.D., P.C. (1)
  154. Michael F. Gallaway, (I);
  155. Debbie L. Killion, (C) Milford CT -Eye Physicians & Surgeons, PC (1)
  156. Darron A. Bacal, (I);
  157. Donna Martin, (C);
  158. Marla Doheny, (C) Minneapolis MN -University of Minnesota (1)*
  159. C. Gail Summers, (I);
  160. Erick Bothun, (I);
  161. Steve Christiansen, (I);
  162. Ann M. Holleschau, (C);
  163. Kim S. Merrill, (V);
  164. Sara J. Downes, (V);
  165. Kathy M. Hogue, (V) Philadelphia PA -Pennsylvania College of Optometry (1)
  166. Mitchell M. Scheiman, (I);
  167. Karen E. Pollack, (C) Sharon MA -Daniel M. Laby, M.D. (
  168. Daniel M. Laby, (I);
  169. Ricky Laby, (C) St.
  170. Louis MO -Cardinal Glennon Children's Hospital (
  171. Oscar A. Cruz, (I);
  172. Bradley V. Davitt, (I);
  173. Emily A. Miyazaki, (C) Waterbury CT -Eye Care Group, PC (1)
  174. Andrew J. Levada, (I);
  175. Tabitha L. Walker, (C);
  176. LeAnne J. Ingala, (V) Wichita KS -Grene Vision Group (
  177. Charles R. Whitfill, (I);
  178. Ruth D. Dannar, (C);
  179. Amy Melissa Wheeler, (V)
  180. *Center received support utilized for this project from an unrestricted grant from Research to Prevent Blindness Inc., New York, New York.
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