Michael X Repka1, Raymond T Kraker2, Jonathan M Holmes3, Allison I Summers4, Stephen R Glaser5, Carmen N Barnhardt6, David R Tien7. 1. Wilmer Ophthalmological Institute, The John Hopkins University, Baltimore, Maryland. 2. Pediatric Eye Disease Investigator Group Coordinating Center, Jaeb Center for Health Research, Tampa, Florida. 3. Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota. 4. Casey Eye Institute, Portland, Oregon. 5. currently in private practice, Rockville, Maryland. 6. Southern California College of Optometry, Fullerton. 7. Pediatric Ophthalmology and Strabismus Associates, Providence, Rhode Island.
Abstract
IMPORTANCE: Initial treatment for amblyopia of the fellow eye with patching and atropine sulfate eyedrops improves visual acuity. Long-term data on the durability of treatment benefit are needed. OBJECTIVE: To report visual acuityat 15 years of age among patients who were younger than 7 years when enrolled in a treatment trial for moderate amblyopia. DESIGN, SETTING, AND PARTICIPANTS: In a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40 to 20/100) were randomly assigned to patching (minimum of 6 h/d) or atropine sulfate eyedrops, 1% (1 drop daily), for 6 months. Treatment after 6 months was at the discretion of the investigator. Two years after enrollment, an unselected subgroup of 188 children were enrolled into long-term follow-up. INTERVENTION: Initial treatment with patching or atropine with subsequent treatment at investigator discretion. MAIN OUTCOMES AND MEASURES: Visual acuity at 15 years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes. RESULTS:Mean visual acuity in the amblyopic eye measured in 147 participants at 15 years of age was 0.14 logMAR (approximately 20/25); 59.9% of amblyopic eyes hadvisual acuity of 20/25 or better and 33.3%, 20/20 or better. Mean interocular acuity difference (IOD) at 15 years of age was 0.21 logMAR (2.1 lines); 48.3% had an IOD of 2 or more lines and 71.4%, 1 or more lines. Treatment (other than spectacles) was prescribed for 9 participants (6.1%) aged 10 to 15 years. Mean IOD was similar at examinations at 10 and 15 years of age (2.0 and 2.1 logMAR lines, respectively; P = .39). Better visual acuity at the 15-year examination was achieved in those who were younger than 5 years at the time of entry into the randomized clinical trial (mean logMAR, 0.09) compared with those aged 5 to 6 years (mean logMAR, 0.18; P < .001). When we compared subgroups based on original treatment with atropine or patching, no significant differences were observed in visual acuity of amblyopic and fellow eyes at 15 years of age (P = .44 and P = .43, respectively). CONCLUSIONS AND RELEVANCE: At 15 years of age, most children treated for moderate amblyopia when younger than 7 years have good visual acuity, although mild residual amblyopia is common. The outcome is similar regardless of initial treatment with atropine or patching. The results indicate that improvement occurring with amblyopia treatment is maintained until at least 15 years of age. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000170.
RCT Entities:
IMPORTANCE: Initial treatment for amblyopia of the fellow eye with patching and atropine sulfate eyedrops improves visual acuity. Long-term data on the durability of treatment benefit are needed. OBJECTIVE: To report visual acuity at 15 years of age among patients who were younger than 7 years when enrolled in a treatment trial for moderate amblyopia. DESIGN, SETTING, AND PARTICIPANTS: In a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40 to 20/100) were randomly assigned to patching (minimum of 6 h/d) or atropine sulfate eyedrops, 1% (1 drop daily), for 6 months. Treatment after 6 months was at the discretion of the investigator. Two years after enrollment, an unselected subgroup of 188 children were enrolled into long-term follow-up. INTERVENTION: Initial treatment with patching or atropine with subsequent treatment at investigator discretion. MAIN OUTCOMES AND MEASURES: Visual acuity at 15 years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes. RESULTS: Mean visual acuity in the amblyopic eye measured in 147 participants at 15 years of age was 0.14 logMAR (approximately 20/25); 59.9% of amblyopic eyes had visual acuity of 20/25 or better and 33.3%, 20/20 or better. Mean interocular acuity difference (IOD) at 15 years of age was 0.21 logMAR (2.1 lines); 48.3% had an IOD of 2 or more lines and 71.4%, 1 or more lines. Treatment (other than spectacles) was prescribed for 9 participants (6.1%) aged 10 to 15 years. Mean IOD was similar at examinations at 10 and 15 years of age (2.0 and 2.1 logMAR lines, respectively; P = .39). Better visual acuity at the 15-year examination was achieved in those who were younger than 5 years at the time of entry into the randomized clinical trial (mean logMAR, 0.09) compared with those aged 5 to 6 years (mean logMAR, 0.18; P < .001). When we compared subgroups based on original treatment with atropine or patching, no significant differences were observed in visual acuity of amblyopic and fellow eyes at 15 years of age (P = .44 and P = .43, respectively). CONCLUSIONS AND RELEVANCE: At 15 years of age, most children treated for moderate amblyopia when younger than 7 years have good visual acuity, although mild residual amblyopia is common. The outcome is similar regardless of initial treatment with atropine or patching. The results indicate that improvement occurring with amblyopia treatment is maintained until at least 15 years of age. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000170.
Authors: J M Holmes; R W Beck; M X Repka; D A Leske; R T Kraker; R C Blair; P S Moke; E E Birch; R A Saunders; R W Hertle; G E Quinn; K A Simons; J M Miller Journal: Arch Ophthalmol Date: 2001-09
Authors: Jonathan M Holmes; Elizabeth L Lazar; B Michele Melia; William F Astle; Linda R Dagi; Sean P Donahue; Marcela G Frazier; Richard W Hertle; Michael X Repka; Graham E Quinn; Katherine K Weise Journal: Arch Ophthalmol Date: 2011-07-11
Authors: Jonathan M Holmes; Roy W Beck; Raymond T Kraker; William F Astle; Eileen E Birch; Stephen R Cole; Susan A Cotter; Sean Donahue; Donald F Everett; Richard W Hertle; Ronald V Keech; Evelyn Paysse; Graham F Quinn; Michael X Repka; Mitchell M Scheiman Journal: J AAPOS Date: 2004-10 Impact factor: 1.220
Authors: Roy W Beck; Pamela S Moke; Andrew H Turpin; Frederick L Ferris; John Paul SanGiovanni; Chris A Johnson; Eileen E Birch; Danielle L Chandler; Terry A Cox; R Clifford Blair; Raymond T Kraker Journal: Am J Ophthalmol Date: 2003-02 Impact factor: 5.258
Authors: Jingyun Wang; Daniel E Neely; Jay Galli; Joshua Schliesser; April Graves; Tina G Damarjian; Jessica Kovarik; James Bowsher; Heather A Smith; Dana Donaldson; Kathryn M Haider; Gavin J Roberts; Derek T Sprunger; David A Plager Journal: J AAPOS Date: 2016-07-12 Impact factor: 1.220
Authors: Duane A Chang; Roger C Ede; Dominic C Chow; Ryan D Souza; Louie Mar A Gangcuangco; Nancy Hanks; Beau K Nakamoto; Brooks Mitchell; Alison T Masutani; Sam Fisk; Cecilia M Shikuma; Jan E Dill Journal: Hawaii J Med Public Health Date: 2015-09
Authors: Tomohiko Yamada; Sarah R Hatt; David A Leske; Pamela S Moke; Nick L Parrucci; J Jeffrey Reese; James B Ruben; Jonathan M Holmes Journal: J AAPOS Date: 2015-04 Impact factor: 1.220
Authors: Jingyun Wang; Hongxin Xu; Bryan De La Cruz; Sarah E Morale; Reed M Jost; David A Leske; Jonathan M Holmes; Eileen E Birch Journal: J AAPOS Date: 2020-03-18 Impact factor: 1.220