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Does overminus lens therapy improve distance control in children with intermittent exotropia?
This randomized clinical trial found that mean distance exotropia control was significantly better among 386 children aged 3 to 10 years treated with overminus spectacles vs nonoverminus spectacles for 12 months; however, after weaning off overminus spectacles, there was little or no difference in distance control between groups. Myopic shift was approximately one-third diopter greater in the overminus than in the nonoverminus group.
Overminus lens therapy improved distance exotropia control in children 3 to 10 years of age but was associated with greater myopic shift, and the improved control did not persist after overminus treatment was discontinued.
This is the first large-scale randomized clinical trial evaluating the effectiveness and safety of overminus spectacle therapy for treatment of intermittent exotropia (IXT).
To evaluate the effectiveness of overminus spectacles to improve distance IXT control.
Design, Setting, and Participants
This randomized clinical trial conducted at 56 clinical sites between January 2017 and January 2019 associated with the Pediatric Eye Disease Investigator Group enrolled 386 children aged 3 to 10 years with IXT, a mean distance control score of 2 or worse, and a refractive error between 1.00 and −6.00 diopters (D). Data analysis was performed from February to December 2020.
Participants were randomly assigned to overminus spectacle therapy (−2.50 D for 12 months, then −1.25 D for 3 months, followed by nonoverminus spectacles for 3 months) or to nonoverminus spectacle use.
Main Outcomes and Measures
Primary and secondary outcomes were the mean distance IXT control scores of participants examined after 12 months of treatment (primary outcome) and at 18 months (3 months after treatment ended) assessed by an examiner masked to treatment group. Change in refractive error from baseline to 12 months was compared between groups. Analyses were performed using the intention-to-treat population.
The mean (SD) age of 196 participants randomized to overminus therapy and 190 participants randomized to nonoverminus treatment was 6.3 (2.1) years, and 226 (59%) were female. Mean distance control at 12 months was better in participants treated with overminus spectacles than with nonoverminus spectacles (1.8 vs 2.8 points; adjusted difference, −0.8; 95% CI, −1.0 to −0.5; P < .001). At 18 months, there was little or no difference in mean distance control between overminus and nonoverminus groups (2.4 vs 2.7 points; adjusted difference, −0.2; 95% CI, −0.5 to 0.04; P = .09). Myopic shift from baseline to 12 months was greater in the overminus than the nonoverminus group (−0.42 D vs −0.04 D; adjusted difference, −0.37 D; 95% CI, −0.49 to −0.26 D; P < .001), with 33 of 189 children (17%) in the overminus group vs 2 of 169 (1%) in the nonoverminus group having a shift higher than 1.00 D.
Conclusions and Relevance
Children 3 to 10 years of age had improved distance exotropia control when assessed wearing overminus spectacles after 12 months of overminus treatment; however, this treatment was associated with increased myopic shift. The beneficial effect of overminus lens therapy on distance exotropia control was not maintained after treatment was tapered off for 3 months and children were examined 3 months later.
ClinicalTrials.gov Identifier: NCT02807350
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Accepted for Publication: January 12, 2021.
Published Online: March 4, 2021. doi:10.1001/jamaophthalmol.2021.0082
Corresponding Author: Angela M. Chen, OD, MS, Jaeb Center for Health Research, 15310 Amberly Dr, Ste 350, Tampa, FL 33647 (firstname.lastname@example.org).
Author Contributions: Ms Hercinovic had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Chen, Erzurum, Chandler, Melia, Suh, Kong, Kraker, Holmes, Cotter.
Acquisition, analysis, or interpretation of data: Chen, Chandler, Hercinovic, Melia, Bhatt, Vricella, Erickson, Miller, Marsh, Bodack, Martinson, Titelbaum, Gray, Holtorf, Kong, Kraker, Rahmani, Shah, Holmes, Cotter.
Drafting of the manuscript: Chen, Erzurum, Chandler, Hercinovic, Titelbaum, Kraker.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Chandler, Hercinovic, Melia, Kraker, Holmes.
Obtained funding: Kraker, Holmes, Cotter.
Administrative, technical, or material support: Bhatt, Vricella, Miller, Gray, Kong, Kraker, Rahmani, Holmes, Cotter.
Supervision: Chen, Erzurum, Chandler, Melia, Suh, Miller, Marsh, Kraker, Holmes, Cotter.
Conflict of Interest Disclosures: None reported.
Funding/Support: Research reported in this publication was supported by grants EY011751, EY023198, EY018810, and EY024333 from the National Eye Institute of the National Institutes of Health.
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Members of the Pediatric Eye Disease Investigator Group (PEDIG):
Clinical Sites: Sites are listed in order by number of participants enrolled (in parentheses). Personnel are listed as (I) for Investigator, (C) for Coordinator, or (E) for Examiner.
Department of Ophthalmology, Texas Children’s Hospital, Houston, TX (22): Evelyn A. Paysse (I); Amit R. Bhatt (I); Kelsie B. Morrison (I); Irene T. Tung (I); Kimberly G. Yen (I); Gihan Romany (C). Children’s Hospital & Medical Center, Omaha, NE (22): Donny W. Suh (I); Whitney R. Brown (I); Rachel M. Smith (I); Carolyn Chamberlain (C); Samiksha Fouzdar Jain (E); Linda A. Morgan (E). Ticho Eye Associates, Chicago Ridge, IL (17): Benjamin H. Ticho (I); Megan Allen (I); Birva K. Shah (I); Deborah A. Clausius (C); Micaela N. Quebbemann (E). Virginia Pediatric Eye Center, Virginia Beach, VA (17): Eric Crouch (I); Earl R. Crouch, Jr (I); Stacy R. Martinson (I); Gaylord G. Ventura (C). Cincinnati Children’s Hospital, Cincinnati, OH (16): Michael E. Gray (I); Melissa L. Rice (I); Neil Vallabh (C); Shemeka Rochelle Forte (E); Miqua Lynn Stewart (E). Children's Mercy Hospitals and Clinics, Kansas City, MO (15): Amy L. Waters (I); Justin D. Marsh (I); Rebecca J. Dent (C); Adriana Marie Ferreira (E); Jennifer N. Qayum (E); Christina M. Twardowski (E). Greater Baltimore Medical Center, Baltimore, MD (14): Mary Louise Z. Collins (I); Allison A. Jensen (I); Maureen A. Flanagan (C); Saman Bhatti (E); Cheryl L. McCarus (E); Tiffany Talia Tolbert (E). Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL (14): Sudhi P. Kurup (I); Rebecca B. Mets-Halgrimson (I); Bahram Rahmani (I); Magdalena Stec (I); Janice B. Zeid (I); Hantamalala Ralay Ranaivo (C); Erika A. De Leon (E); Anthony Jeffrey Klauer (E); Vivian Tzanetakos (E); Laura McCoy Vrablec (E). College of Optometry, State University of New York, New York, NY (14): Marilyn Vricella (I); Monica Joao (C); Shelby Leach (E); Rochelle Mozlin (E); Daniella Rutner (E); Erica L. Schulman-Ellis (E). University Eye Center at Ketchum Health, Anaheim, CA (13): Susan A. Cotter (I); Angela M. Chen (I); Silvia Han (I); Catherine L. Heyman (I); Reena A. Patel (I); Dashaini V. Retnasothie (I); Sue M. Parker (C); Desireh Akhamzadeh (E); Kristine Huang (E). Houston Eye Associates, The Woodlands, TX (13): Aaron M. Miller (I); Jorie L. Jackson (C); Monsey L. Alexander (E); Angela C. Dillon (E). Boston Medical Center, Boston, MA (11): Stephen P. Christiansen (I); Kara C. LaMattina (I); Jenna R. Titelbaum (I); Marissa G. Fiorello (C); Merit Gorgy (C); Nina Tamashunas (C); Natalie Sadlak (C); Wanjiku G. Githere (C); Jiwoo Kim (C); Abigail R. Goldberg (C); Mary A. Tresvalles (C); Kelly M. Castle (E); Jennifer E. Lambert (E). Nemours Children’s Clinic, Jacksonville, FL (10): John W. Erickson (I); Amy Thrift (C); Charlotte Ann Louise Reaser (E). UPMC Children’s Eye Center of Children’s Hospital of Pittsburgh, Pittsburgh, PA (10): Ken K. Nischal (I); Craig A. Luchansky (I); Ellen B. Mitchell (I); Sara Otaibi (I); Matthew S. Pihlblad (I); Lauren M. Runkel (C); Kaajal Nanda (E); Katherine Sanchez (E); Christin L. Sylvester (E). Arkansas Children’s Hospital/University of Arkansas Medical Sciences, Little Rock, AR (9): Paul H. Phillips (I); Adriana Paula Grigorian (I); Hannah L. Holtorf (I); Beth Colon (C); Shawn L. Cupit (E). Southern College of Optometry, Memphis, TN (9): Marie I. Bodack (I); Randy C. Brafford (C); Alicia A. Groce (E); Marc B. Taub (E). Illinois College of Optometry (ICO), Chicago, IL (8): Yi Pang (I); Megan Allen (I); Huizi Yin (I); Elyse Nylin (C). Texas Tech University Health Science Center, Lubbock, TX (8): Lingkun Kong (I); Misty Rae Sisneros (C); Connie J. Crossnoe (E). Salus University/Pennsylvania College of Optometry, Philadelphia, PA (8): Erin C. Jenewein (I); Stanley W. Hatch (I); Jenny Myung (I); Ruth Y. Shoge (I); Karen E. Pollack (C); Mitchell M. Scheiman (E). UAB School of Optometry, Birmingham, Alabama (7): Tamara S. Oechslin (I); Marcela Frazier (I); Katherine K. Weise (I); Jenifer Montejo (C); Margaret Kathleen Bailey (E); Kristine B. Hopkins (E); Candice I. Turner (E). Concord Ophthalmologic Associates, Concord, NH (7): Christie L. Morse (I); Caroline C. Fang (E); Jacqueline Kathryn Gavin (E). Pediatric Ophthalmology, PC, Grand Rapids, Michigan (7): Patrick J. Droste (I); Robert J. Peters (I); Jan Hilbrands (C); Kylie L. Smith (E). Mayo Clinic, Rochester, MN (7): Erick D. Bothun (I); Brian G. Mohney (I); Tomohiko Yamada (I); Suzanne M. Wernimont (C); Adam M. Hauglid (E); Lindsay D. Klaehn (E); Andrea M. Kramer (E); Laura Lepor (E); Sarah R. Mickow (E). Department of Ophthalmology and Visual Sciences, University of Kentucky, Lexington, KY (6): Christi M. Willen (I); Julia L. Stevens (I); Yvonne R. James (C); Michele Reg (C); John Mark Franklin (E). CHU-Sainte-Justine, Montreal (6): Rosanne Superstein (I); Maryse Thibeault (C); Afifa Argoubi (E); Charlotte Riguidel (E); Alexandra Rodrigues (E). Dean A. McGee Eye Institute, University of Oklahoma, Oklahoma City, OK (6): R. Michael Siatkowski (I); Janine E. Collinge (I); Maria E. Lim (I); Tammy Yanovitch (I); Alisha N. Brewer (C); Laurie Parrott (E); Lauren M. Pendarvis (E). Stanford University, Palo Alto, CA (6): Scott R. Lambert (I); Deborah Alcorn (I); Euna B. Koo (I); Naz Jehangir (C); Kristina Liu (C); Tawna L. Roberts (E); Amanda M. Yonkers (E). Wilmer Institute, Baltimore, MD (5): Michael X. Repka (I); Courtney Kraus (I); Xiaonong Liu (C); Alex Christoff (E). Indiana University School of Optometry, Bloomington, IN (5): Don W. Lyon (I); Katie S. Connolly (I); Kristy M. Dunlap (C). Pediatric Eye Specialists, Chattanooga, TN (5): Rachel L. Brown (I); Edward A. Peterson (I). Duke University Eye Center, Durham, NC (5): Nathan L. Cheung (I); Sarah K. Jones (C); Sandra Holgado (E); Rachel N. Loud (E); Ivonne J. Rodriguez (E). Helen DeVos Children’s Hospital Pediatric Ophthalmology, Grand Rapids, MI (5): Brooke E. Geddie (I); Julie A. Conley (I); Elisabeth T. Wolinski (C); Sonia Manuchian (E); Katie L. Patterson (E); Samantha K. Rosen (E). Children’s Eye Care PC, West Bloomfield, MI (5): Lisa Bohra (I); Elena M. Gianfermi (I); Susan Nicole Perzyk (C); Stephen Michael Burwell (E); Mary Ann DeYoung-Smith (E); Lauren Marozas (E); Judy Lynn Petrunak (E); Martha Mary Wright (E). Wolfe Eye Clinic, West Des Moines, IA (5): Derek P. Bitner (I); Alexis C. Hahn (C); Lisa M. Fergus (E). University of Florida, Gainesville, FL (4): Swati Agarwal-Sinha (I); Casey J. Beal (I); Shannon Hampton (C); Kati M. Ostvig (E). Midwestern University Therapy Institute, Glendale, AZ (4): Alicia E. Feis (I); Caitlin C. Miller (I); Kelly D. Varney (I); Tracy A. Bland (C); Christina A. Esposito (E); Matthew K. Roe (E). Riley Hospital for Children, Indianapolis, IN (4): Kathryn M. Haider (I); Charline S. Boente (I); Heather A. Smith (I); Michele E. Whitaker (C). The Emory Eye Center, Atlanta, GA (3): Jason H. Peragallo (I); Amy K. Hutchinson (I); Phoebe D. Lenhart (I); Natalie C. Weil (I); Judy L. Brower (C); Alex Frederick Lyons (E); Shane P. Mulvihill (E); Marla J. Shainberg (E). St Luke’s Children’s Ophthalmology, Boise, ID (3): Katherine A. Lee (I); Laurie A. Cartwright (C); Kevin R. Gertsch (E). The Ohio State University, Columbus, OH (3): Marjean T. Kulp (I); Jennifer S. Fogt (I); Steven T. Manning (I); Ann M. Morrison (I); Maureen D. Plaumann (I); Erica Rose Shelton (I); Freda Dallas (C); Nancy E. Stevens (C); Michelle J. Buckland (E); Andrew J. Toole (E). Nova Southeastern University College of Optometry, The Eye Institute, Ft Lauderdale, FL (3): Cristina L. Law (I); Deborah M. Amster (I); Amar Sayani (I); Felicia Jean Timmermann (C); Michael J. Au (E); Katherine E. Green (E); Jacqueline Rodena (E); Yin C. Tea (E); Julie A. Tyler (E). University of Houston College of Optometry, Houston, TX (3): Ruth E. Manny (I); Heather A. Anderson (I); Debra C. Currie (I); Muriel M. Martinez (I). Eye Care Associates, Inc, Poland, OH (3): S. Ayse Erzurum (I); Alysa Christiansen (C); Zainab Dinani (E). Western University College of Optometry, Pomona, CA (3): Ida Chung (I); Kimberly R. Walker (I); Jennifer Baker (C); Elaine C. Ramos (E). Akron Children’s Hospital, Akron, OH (2): Casandra S. Solis (I); Ana Juric (C); Isabel Ricker (C); Tawna Roberts (E); Palak B. Wall (E). The Eye Specialist Center, LLC, Munster, IN (2): Birva K. Shah (I); Benjamin H. Ticho (E). UCSF Department of Ophthalmology, San Francisco, CA (2): Alejandra de Alba Campomanes (I); Yizhuo Bastea-Forte (C); Laura Kate Chalkley (E); Karen Cooper (E). Pediatric Eye Associates, Wilmette, IL (2): Lisa C. Verderber (I); Deborah R. Fishman (I); Roberta A. Forde (C). Tufts Medical Center, Boston, MA (1): Catherine S. Choi (I); Sara Galinko (C); Shelley J. Klein (E). Alberta Children's Hospital, Calgary (1): William F. Astle (I); Emi Nicole Sanders (C); Catriona I. Kerr (E); Heather N. Sandusky (E); Shannon L. Steeves (E). Medical University of South Carolina, Storm Eye Institute, Charleston, SC (1): Edward W. Cheeseman (I); Mae M. Peterseim (I); Carol U. Bradham (C). Gundersen Health System, La Crosse, WI (1): David L. Nash (I); Sara R. Meyers (C); Fabiana Berns (E). Loma Linda University Eye Institute, Loma Linda, CA (1): Timothy W. Winter (I); Marcia M. Easterly (C); Rosalynn Nguyen-Strongin (E). University of Minnesota–Minnesota Lions Children’s Eye Clinic, Minneapolis, MN (1): Sara J. Downes (I); Sasha Strul (I); Ann M. Holleschau (C); Laura M. May (E); Kim S. Merrill (E); Anna I. Schweigert (E). OHSU Casey Eye Institute, Portland, OR (1): Allison I. Summers (I); Paula K. Rauch (C); Grant Andrew Casey (E); Kevin M. Woodruff (E). Pacific University College of Optometry, Portland, OR (1): Paula A. Luke (I); Richard London (I); Jayne L. Silver (C); Ryan C. Bulson (E); James J. Kundart (E).
PEDIG Coordinating Center–Tampa, FL: Raymond T. Kraker, Roy W. Beck, Gillaine Alvarez, Darrell S. Austin, Nicole M. Boyle, Danielle L. Chandler, Patricia L. Connelly, Courtney L. Conner, Trevano W. Dean, Quayleen Donahue, Brooke P. Fimbel, Robert J. Henderson, Amra Hercinovic, James E. Hoepner, Joseph D. Kaplon, Zhuokai Li, B. Michele Melia, Julianne L. Robinson, Jennifer A. Shah, David O. Toro, Rui Wu.
Intermittent Exotropia Study 5 Planning Committee: Angela M. Chen (Co-Chair), S. Ayse Erzurum (Co-Chair), Jonathan M. Holmes, Danielle L. Chandler, David A. Leske, Raymond T. Kraker, Roy W. Beck, Eileen E. Birch, Michael X. Repka, David K. Wallace, Allison A. Jensen, Reena A. Patel, B. Michele Melia, Courtney L. Conner.
PEDIG Executive Committee: Susan A. Cotter (Co-chair), Jonathan M. Holmes (Co-chair), Roy W. Beck, Eileen E. Birch, Angela M. Chen (2017-18), Stephen P. Christiansen (2018-present), Laura B. Enyedi (2014-16), S. Ayse Erzurum (2016-present), Donald F. Everett, Sharon F. Freedman (2016-18), William V. Good (2017-19), Raymond T. Kraker, Katherine A. Lee (2014-16), Richard London (2018-present), Vivian M. Manh (2016-18), Ruth E. Manny (2017-19), David G. Morrison (2018-19), Stacy L. Pineles (2019-present), Hantamalala Ralay Ranaivo (2019-present), Michael X. Repka, Scott T. Ruark (2018-19), Bonita R. Schweinler (2016-18), Jayne L. Silver (2014-16), Allison I. Summers (2019-present), Lisa C. Verderber (2015-17), David K. Wallace, Katherine K. Weise (2019-present).
Strabismus Steering Committee: Amit Bhatt (2019-present), Eileen E. Birch, Danielle L. Chandler, Angela M. Chen (2016-present), Patricia Cobb (2019), Susan A. Cotter, Eric R. Crouch (2015-18), Trevano W. Dean (2015-18), Sean P. Donahue (2010-present), S. Ayse Erzurum (2016-present), Michael E. Gray (2017), Kammi B. Gunton (2016-17), Sarah R. Hatt, Jonathan M. Holmes, Erin C. Jenewein (2018), Raymond T. Kraker, Courtney Kraus (2018), Sudhi P. Kurup (2019), Elizabeth L. Lazar (2014-18), Zhuokai Li (2020-present), Justin D. Marsh (2018-19), Michele Melia, David G. Morrison (2018-present), Yi Pang (2017-18), Sue M. Parker (2017-18), Reena Patel (2016-17), Michael X. Repka, Dashaini V. Retnasothie (2019), Tawna L. Roberts (2017), Allyson Sala (2016-17), Elyse Nylin (2019-present), Allison I. Summers (2018-present), Marilyn Vricella (2019-present), Tomohiko Yamada (2015-16).
National Eye Institute: Donald F. Everett.
Data and Safety Monitoring Committee: Marie Diener-West (chair), John D. Baker, Barry Davis, Dale L. Phelps, Stephen W. Poff, Richard A. Saunders, Lawrence Tychsen.
Meeting Presentation: This paper was presented at the Annual Meeting of the American Academy of Optometry; October 7, 2020; virtual meeting; and the Annual Meeting of the Association for Pediatric Ophthalmology and Strabismus; April 13, 2021; virtual meeting.
Data Sharing Statement: See Supplement 3.
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