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Randomized Controlled Trial
. 2019 Feb;126(2):305-317.
doi: 10.1016/j.ophtha.2018.08.034. Epub 2018 Sep 3.

A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia

Pediatric Eye Disease Investigator Group; Writing Committee; Sean P Donahue  1 , Danielle L Chandler  2 , Jonathan M Holmes  3 , Brian W Arthur  4 , Evelyn A Paysse  5 , David K Wallace  6 , David B Petersen  7 , B Michele Melia  2 , Raymond T Kraker  2 , Aaron M Miller  8
Affiliations
Randomized Controlled Trial

A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia

Pediatric Eye Disease Investigator Group et al. Ophthalmology. 2019 Feb.

Erratum in

  • Corrigendum.
    [No authors listed] [No authors listed] Ophthalmology. 2020 Nov;127(11):1590. doi: 10.1016/j.ophtha.2020.07.041. Ophthalmology. 2020. PMID: 33097115 No abstract available.

Abstract

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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Conflict of interest statement

Conflict of Interest: No conflicting relationships exist for any author.

Figures

Figure 1.
Figure 1.. Flow of Participants through Study.
BLRc = bilateral lateral rectus muscle recession; R&R = unilateral lateral rectus recession combined with a medial rectus resection in same eye. *One participant in the R&R group was withdrawn from the study without undergoing surgery.
Figure 2.
Figure 2.. Suboptimal Surgical Outcome By 3 Years (N=197).
Cumulative probability of suboptimal surgical outcome by 3 years from Kaplan-Meier analysis. Treatment-group difference of BLRc minus R&R = 9% (−6% to 23%). BLRc = bilateral lateral rectus muscle recession; R&R = unilateral lateral rectus recession combined with a medial rectus resection in same eye
Figure 3:
Figure 3:. Reoperation by 3 Years (N=197).
BLRc = bilateral lateral rectus muscle recession; R&R = unilateral lateral rectus recession combined with a medial rectus resection in same eye; XT = exotropia; ET = esotropia
Figure 4a and 4b:
Figure 4a and 4b:. Baseline vs. 3-Year PACT Magnitude (N=86 for BLRc and 77 for R&R) for Distance (4a) and Near (4b) Deviations.
A deviation is defined as a tropia (O) if a tropia was present by cover/uncover test at 3 years; otherwise it was defined as phoria (X). BLRc = bilateral lateral rectus muscle recession; R&R = unilateral lateral rectus recession combined with a medial rectus resection in same eye
See this image and copyright information in PMC

Comment in

References

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    1. Yamada T, Hatt SR, Leske DA, Holmes JM. Health-related quality of life in parents of children with intermittent exotropia. J AAPOS 2011;15:135–9. - PMC - PubMed
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