Abstract
Purpose: To report 8-year outcomes from a randomized controlled trial (RCT) comparing bilateral lateral rectus muscle recession (BLRc) with unilateral recession-resection (R&R) for childhood intermittent exotropia (IXT). Design: Eight-year follow-up of RCT cohort. Participants: Of 197 randomized participants, 123 agreed to continue follow-up after the 3-year outcome visit (baseline age, 3–< 11 years; basic-type IXT, 15–40 prism diopters [Δ] by prism and alternate cover test [PACT]; baseline stereoacuity, ≤ 400 arcsec; no prior surgery). Methods: After the RCT primary outcome at 3 years, annual follow-up from 4 through 8 years with treatment at investigator discretion. Main Outcome Measures: Suboptimal surgical outcome by 8 years after randomization, defined as any of the following at any visit: exotropia of 10 Δ or more by simultaneous prism cover test (SPCT) at distance or near, constant esotropia (ET) of 6 Δ or more by SPCT at distance or near, loss of near stereoacuity by 0.6 log arcsec or more from baseline, or reoperation. Secondary outcomes included (1) reoperation by 8 years and (2) complete or near-complete resolution at 8 years, defined as exodeviation of less than 10 Δ by SPCT and PACT at distance and near and 10 Δ or more reduction from baseline by PACT at distance and near, ET of less than 6 Δ at distance and near, no decrease in stereoacuity by 0.6 log arcsec or more from baseline, and no reoperation or nonsurgical treatment for IXT. Results: The Kaplan-Meier cumulative probability of suboptimal surgical outcome through 8 years was 68% (55 events among 101 at risk) for BLRc and 53% (42 events among 96 at risk) for R&R (difference, 15%; 95% confidence interval [CI], –2% to 32%; P = 0.08). Complete or near-complete resolution at 8 years occurred in 15% (7/46) for BLRc and 37% (16/43) for R&R (difference, –22%; 95% CI, –44% to –0.1%; P = 0.049). The cumulative probability of reoperation was 30% for BLRc and 11% for R&R (difference, 19%; 95% CI, 2%–36%; P = 0.049). Conclusions: Despite no significant difference for the primary outcome, the 95% CI did not exclude a moderate benefit of R&R, which together with secondary outcomes suggests that unilateral R&R followed by usual care may yield better long-term outcomes than BLRc followed by usual care for basic-type childhood IXT using these surgical doses. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Original language | English (US) |
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Pages (from-to) | 98-106 |
Number of pages | 9 |
Journal | Ophthalmology |
Volume | 131 |
Issue number | 1 |
DOIs | |
State | Published - Jan 2024 |
Funding
Supported by the National Eye Institute, National Institutes of Health , Bethesda, Maryland (grant nos.: EY011751 , EY023198 , EY018810 , and EY024333 ). The funding organization had no role in the design or conduct of this research. Supported by the National Eye Institute, National Institutes of Health, Bethesda, Maryland (grant nos.: EY011751, EY023198, EY018810, and EY024333). The funding organization had no role in the design or conduct of this research. C.L.: Consultant – Bayer; Financial support – Innovation Fund [SEAMO], Social Sciences Health and Humanities Research Council J.M.H.: Nonfinancial support – Horizon Therapeutics HUMAN SUBJECTS: Human subjects were included in this study. The study was funded by the National Eye Institute of the National Institutes of Health and conducted according to the tenets of the Declaration of Helsinki by the Pediatric Eye Disease Investigator Group (PEDIG) at 35 academic and community-based clinical sites. The protocol and Health Insurance Portability and Accountability Act (HIPAA)-compliant informed consent forms were approved by institutional review boards for each site, and a parent or guardian of each study participant gave written informed consent. Obtained funding: N/A; Study was performed as part of the authors' regular employment duties. No additional funding was provided. The study was funded by the National Eye Institute of the National Institutes of Health and was conducted according to the tenets of the Declaration of Helsinki by the Pediatric Eye Disease Investigator Group at 35 academic and community-based clinical sites (Jaeb Center for Health Research IRB). The protocol and Health Insurance Portability and Accountability Act-compliant informed consent forms were approved by institutional review boards for each site, and a parent or guardian of each study participant provided written informed consent. The study is listed on www.clinicaltrials.gov (identifier, NCT01032603) 11 ; the full protocol is available at www.pedig.net (accessed February 6, 2023). C.L.: Consultant – Bayer; Financial support – Innovation Fund [SEAMO], Social Sciences Health and Humanities Research Council
Keywords
- Intermittent exotropia
- Pediatric ophthalmology
- Strabismus
ASJC Scopus subject areas
- Ophthalmology