TY - JOUR
T1 - A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia
AU - Pediatric Eye Disease Investigator Group
AU - Writing Committee
AU - Donahue, Sean P.
AU - Chandler, Danielle L.
AU - Holmes, Jonathan M.
AU - Arthur, Brian W.
AU - Paysse, Evelyn A.
AU - Wallace, David K.
AU - Petersen, David B.
AU - Melia, B. Michele
AU - Kraker, Raymond T.
AU - Miller, Aaron M.
N1 - Funding Information:
Supported by the National Eye Institute , National Institutes of Health , Bethesda, Maryland (grant nos.: EY011751 , EY023198 , and EY018810 ). The funding organization had no role in the design or conduct of this research.
Funding Information:
The study was supported through a cooperative agreement with the National Eye Institute, National Institutes of Health, Bethesda, Maryland, and was conducted according to the tenets of the Declaration of Helsinki by the Pediatric Eye Disease Investigator Group at academic- and community-based clinical sites. The protocol and Health Insurance Portability and Accountability Act–compliant informed consent forms were approved by institutional review boards, and a parent or guardian of each study participant gave written informed consent. An independent data and safety monitoring committee provided study oversight. The study is registered at www.clinicaltrials.gov (identifier, NCT01032603 ; accessed June 1, 2018). The full study protocol is available on the Pediatric Eye Disease Investigator Group web site ( www.pedig.net ; accessed June 1, 2018).
Publisher Copyright:
© 2018 American Academy of Ophthalmology
PY - 2019/2
Y1 - 2019/2
N2 - Purpose: To compare long-term outcomes after bilateral lateral rectus recession (BLRc) or unilateral lateral rectus recession combined with medial rectus resection in the same eye (R&R) for primary treatment of childhood intermittent exotropia (IXT). Design: Multicenter, randomized clinical trial. Participants: One hundred ninety-seven children 3 to younger than 11 years of age with basic-type IXT, a largest deviation by prism and alternate cover test at any distance of 15 to 40 prism diopters (PD), and near stereoacuity of at least 400 seconds of arc. Methods: Random assignment to BLRc or R&R and masked examinations conducted every 6 months after surgery for 3 years. Main Outcome Measures: Proportion of participants meeting suboptimal surgical outcome by 3 years, defined as: (1) exotropia of 10 PD or more at distance or near using simultaneous prism and cover test (SPCT); or (2) constant esotropia of 6 PD or more at distance or near using SPCT; (3) loss of 2 octaves or more of stereoacuity from baseline, at any masked examination; or (4) reoperation without meeting any of these criteria. Results: Cumulative probability of suboptimal surgical outcome by 3 years was 46% (43/101) in the BLRc group versus 37% (33/96) in the R&R group (treatment group difference of BLRc minus R&R, 9%; 95% confidence interval [CI], –6% to 23%). Reoperation by 3 years occurred in 9 participants (10%) in the BLRc group (8 of 9 met suboptimal surgical outcome criteria) and in 4 participants (5%) in the R&R group (3 of 4 met suboptimal surgical outcome criteria; treatment group difference of BLRc minus R&R, 5%; 95% CI, –2% to 13%). Among participants completing the 3-year visit, 29% (25 of 86) in the BLRc group and 17% (13 of 77) in the R&R group underwent reoperation or met suboptimal surgical outcome criteria at 3 years (treatment group difference of BLRc minus R&R, 12%; 95% CI, –1% to 25%). Conclusions: We did not find a statistically significant difference in suboptimal surgical outcome by 3 years between children with IXT treated with BLRc compared with those treated with R&R. Based on these findings, we are unable to recommend one surgical approach over the other for childhood IXT.
AB - Purpose: To compare long-term outcomes after bilateral lateral rectus recession (BLRc) or unilateral lateral rectus recession combined with medial rectus resection in the same eye (R&R) for primary treatment of childhood intermittent exotropia (IXT). Design: Multicenter, randomized clinical trial. Participants: One hundred ninety-seven children 3 to younger than 11 years of age with basic-type IXT, a largest deviation by prism and alternate cover test at any distance of 15 to 40 prism diopters (PD), and near stereoacuity of at least 400 seconds of arc. Methods: Random assignment to BLRc or R&R and masked examinations conducted every 6 months after surgery for 3 years. Main Outcome Measures: Proportion of participants meeting suboptimal surgical outcome by 3 years, defined as: (1) exotropia of 10 PD or more at distance or near using simultaneous prism and cover test (SPCT); or (2) constant esotropia of 6 PD or more at distance or near using SPCT; (3) loss of 2 octaves or more of stereoacuity from baseline, at any masked examination; or (4) reoperation without meeting any of these criteria. Results: Cumulative probability of suboptimal surgical outcome by 3 years was 46% (43/101) in the BLRc group versus 37% (33/96) in the R&R group (treatment group difference of BLRc minus R&R, 9%; 95% confidence interval [CI], –6% to 23%). Reoperation by 3 years occurred in 9 participants (10%) in the BLRc group (8 of 9 met suboptimal surgical outcome criteria) and in 4 participants (5%) in the R&R group (3 of 4 met suboptimal surgical outcome criteria; treatment group difference of BLRc minus R&R, 5%; 95% CI, –2% to 13%). Among participants completing the 3-year visit, 29% (25 of 86) in the BLRc group and 17% (13 of 77) in the R&R group underwent reoperation or met suboptimal surgical outcome criteria at 3 years (treatment group difference of BLRc minus R&R, 12%; 95% CI, –1% to 25%). Conclusions: We did not find a statistically significant difference in suboptimal surgical outcome by 3 years between children with IXT treated with BLRc compared with those treated with R&R. Based on these findings, we are unable to recommend one surgical approach over the other for childhood IXT.
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U2 - 10.1016/j.ophtha.2018.08.034
DO - 10.1016/j.ophtha.2018.08.034
M3 - Article
C2 - 30189281
AN - SCOPUS:85054708114
VL - 126
SP - 305
EP - 317
JO - Ophthalmology
JF - Ophthalmology
SN - 0161-6420
IS - 2
ER -