Refractive Error Change and Overminus Lens Therapy for Childhood Intermittent Exotropia
Authors:   Writing Committee for the Pediatric Eye Disease Investigator Group,   Pediatric Eye Disease Investigator Group, Alexander Monsey L , Allen Megan , Alluri Sreevardhan , Amster Deborah M , Anderson Heather A , Argoubi Afifa , Astle William F , Austin Darrell S , Bailey Maragaret K , Baker John D , Beaulieu Wesley T , Beck Roy W , Berns Fabiana , Bhatt Amit R , Birch Eileen E , Bitner Derek P , Bland Tracy A , Bodack Marie I , Boente Charline S , Bohra Lisa , Bond Lezlie L , Bothun Erick D , Boyle Nicole M , Brafford Randy C , Castle Kelly M , Chamberlain Carolyn , Cheung Nathan L , Christiansen Stephen P , Christoff Alex , Chung Ida , Cioffi Katherine R , Clausius Deborah A , Cobb Patricia , Collins Mary Louise Z , Colon Beth J , Conley Julie A , Conner Courtney L , Connolly Katie S , Cooper Karen , Crossnoe Connie J , Crouch Eric R , Cupit Shawn L , Curtis Linda T , Cutrer Beth M , Davis Barry , de Alba Campomanes Alejandra G , De Leon Erika A , Dean Trevano W , Diener-West Marie I , Dillon Angela C , Dinani Zainab , Donahue Quayleen , Donahue Sean P , Droste Patrick J , Ecerova Zuzana , Eltzroth Jillian M , Esposito Christina A , Evans Patricia L , Everett Donald F , Fang Caroline C , Feis Alicia E , Fergus Lisa M , Fimbel Brooke P , Fishman Deborah R , Flanagan Maureen A , Forde Roberta A , Fouzdar Jain Samisksha , Franklin John Mark , Frazier Marcela , Gafford Jennifer B , Geddie Brooke E , Gertsch Kevin R , Gianfermi Elena , Gray Michael E , Grigorian Adriana P , Gunton Kammi B , Hahn Alexis C , Hahn-Parrott Laurie , Haider Kathryn M , Haley Wendy Jean , Hatch Stanley W , Hatt Sarah R , Henderson Robert J , Heyman Catherine L , Higgins Rosemary D , Hilbrands Jan , Hoepner James E , Holleschau Ann M , Holtorf Hannah L , Hoover Darren L , Hopkins Kristine B , Huang Kristine , Hutchinson Amy K , James Yvonne R , Jastrzemsbki Benjamin G , Jenewein Erin C , Jensen Allison A , Jhajj Jasleen K , Jones Sarah K , Jordan Catherine O , Kaplon Joseph D , Khan Shabana , Klaehn Lindsay D , Kong Lingkun , Koontz Emily R , Koutnik Cassandra A , Kramer Andrea M , Kraus Courtney L , Krueger Samantha L , Kulp Marjean T , Kurup Sudhi P , LaMattina Kara C , Lambert Jennifer E , Lambert Scott R , Law Cristina L , Lazar Elizabeth L , Leach Shelby , Lee Katherine A , Leske David A , Li Zhuokai , Lim Maria E , Liu Xiaonong , Lorenzana Ingryd , Loud Rachel N , Lyon Don W , Lyons Alex F , Manuchian Sonia , Marozas Lauren , Marsh Justin D , Martinson Stacy R , May Laura M , McCoy Vrablec Laura , McMurtrey J. Ryan , Meil Gail C , Melia B. Michele , Merrill Kim S , Mets-Halgrimson Rebecca B , Meyers Sara R , Miller Aaron M , Miller Caiytlin C , Mohney Brian G , Montejo Jenifer , Morgan Linda , Morrison Kelsie B , Morrison Ann M , Morrison David G. , Myung Jenny , Nash David L , Nylin Elyse , Oechslin Tamara S , Olvera Maria N , Ortiz Gillaine , Oseguera Teresa , Pang Yi , Parker Sue M , Patel Reena A , Paysse Evelyn A , Peragallo Jason H , Perzyk Susan N , Peters Robert J , Phillips Paul H , Plaumann Maureen D , Plum Larry W , Poff Stephen W , Pollack Karen E , Qayum Jennifer N , Quebbemann Micaela N , Raghuram Aparna , Rahmani Bahram , Ralay Ranaivo Hantamalala , Repka Michael X , Retnasothie Dashaini V , Roberts Tawna L , Robinson Julianne L , Roe Matthew K , Romany Gihan , Rutner Daniella , Sala Allyson , Sanders Emi N , Saunders Richard A , Sayani Amar , Scheiman Mitchell M , Schulman-Ellis Erica L , Shah Birva K , Shah Veeral S , Shelton Erica R , Siatkowski R. Michael , Slinger Kristin E , Smith Rachel M , Solis Casandra S , Stec Magdalena , Stevens Nancy E , Stevens Julia L , Stewart Miqua L , Strul Sasha , Stutz Kathleen M , Suh Donny W , Summers Allison I , Superstein Roseanne , Sutherland Desirae R , Tamkins Susanna M , Taub Marc B , Thibeault Maryse , Titelbaum Jenna R , Tolbert Tiffany T , Toole Andrew J , Toro David O , Tung Irene T , Twardowski Christina M , Tychsen Lawrence , Tzanetakos Vivian , Varney Kelly D , Ventura Gaylord G , Verderber Lisa C , Walker Kimberly R , Wall Palak B , Wallace David K , Wang Jingyun , Weise Katherine K , Wernimont Suzanne M , Willen Christi M , Wolinski Elisabeth T , Woodard Victoria C , Wright Martha M , Yamada Tomohiko , Yen Kimberly G , Yonkers Amanda M , Freedman Sharon F , Christian Melanie L , Crouch Earl R , Enyedi Laura B , Good William V , Jackson Jorie L , London Richard , Manh Vivian M , Manny Ruth E , Morrell Beth A , Petersen David B , Pineles Stacy L , Rogers David L , Ruark Scott T , Schweinler Bonita R , Silver Jayne L , Chen Angela M. , Erzurum S. Ayse , Chandler Danielle L. , Hercinovic Amra , Wu Rui , Vricella Marilyn , Waters Amy L. , Ticho Benjamin H. , Erickson John W. , Han Silvia , McDowell Paula S. , Li Zhuokai , Kraker Raymond T. , Holmes Jonathan M. , Cotter Susan A. 
Published: March 2024

Importance

Increased myopic shift was found to be associated with 1 year of overminus spectacle treatment for children with intermittent exotropia (IXT). Persistence of myopic shift after discontinuing overminus spectacles is unknown.

Objective

To compare refractive error change over 3 years in children with IXT originally treated with overminus vs nonoverminus spectacles.

Design, Setting, and Participants

This study was an 18-month extension of the Trial of Overminus Spectacle Therapy for Intermittent Exotropia cohort, which previously randomized children aged 3 to 10 years with IXT and baseline spherical equivalent refractive error (SER) between −6.00 diopters (D) and 1.00 D to overminus spectacles (−2.50 D for 12 months, −1.25 D for 3 months, and nonoverminus for 3 months) or nonoverminus spectacles. Children were recruited from 56 sites from July 2010 to February 2022. Data were analyzed from February 2022 to January 2024.

Interventions

After trial completion at 18 months, participants were followed up at 24 and 36 months. Treatment was at investigator discretion from 18 to 36 months.

Main Outcomes and Measures

Change in SER (cycloplegic retinoscopy) from baseline to 36 months.

Results

Of 386 children in the Trial of Overminus Spectacle Therapy for Intermittent Exotropia, 223 (57.8%) consented to 18 months of additional follow-up, including 124 of 196 (63.3%) in the overminus treatment group and 99 of 190 (52.1%) in the nonoverminus treatment group. Of 205 children who completed 36-month follow-up, 116 (56.6%) were female, and the mean (SD) age at randomization was 6.2 (2.1) years. Mean (SD) SER change from baseline to 36 months was greater in the overminus group (−0.74 [1.00] D) compared with the nonoverminus group (−0.44 [0.85] D; adjusted difference, −0.36 D; 95% CI, −0.59 to −0.12;P = .003), with 30 of 112 (26.8%) in the overminus group having more than 1 D of myopic shift compared with 14 of 91 (15%) in the nonoverminus group (risk ratio, 1.8; 95% CI, 1.0-3.0). From 12 to 36 months, mean (SD) myopic shift was −0.34 (0.67) D and −0.36 (0.66) D in the overminus and nonoverminus groups, respectively (adjusted difference, −0.001 D; 95% CI, −0.18 to 0.18;P = .99).

Conclusions and Relevance

The greater myopic shift observed after 1 year of −2.50-D overminus lens treatment remained at 3 years. Both groups had similar myopic shift during the 2-year period after treatment weaning and cessation. The risk of myopic shift should be discussed with parents when considering overminus lens treatment.

Trial Registration

ClinicalTrials.gov Identifier:NCT02807350