The Early vs Late Infantile Strabismus Surgery Study: do sources for bias exist in this non-randomised trial? Early vs Late Infantile Strabismus Surgery Study Group

Abstract

Background: The Early vs Late Infantile Strabismus Surgery Study Group investigates whether early or late surgery is preferable in infantile convergent strabismus, in a non-randomised, prospective, multicentre clinical trial. The current state of the study after end of recruitment is reported here, focusing on the question of possible sources for bias in this non-randomised trial.

Method: The prognostic factors were analysed at baseline in order to check for imbalances between the two treatment groups. Reasons for possible differences are discussed.

Results: There is no evidence for clinically relevant inhomogeneities between the two groups concerning the distribution of the three prognostic factors spherical equivalent, degree of amblyopia, and limitation of abduction. The fourth prognostic factor, horizontal angle of squint, differs significantly between the two groups.

Conclusion: In the analysis of the final results we may have to account for differences in angle of squint at baseline by its inclusion as a covariate or by stratification.

Figure 1

Histogram of spherical equivalents at baseline for early and late surgery group: the differences between spherical equivalents are neither statistically significant nor clinically relevant.

Figure 2

Histogram of horizontal angles of squint at baseline for early and late surgery group. Large angles of squint are observed more frequently in the early group. Mean horizontal angles of squint differ by 2.1 degrees between both groups This difference is highly significant (p=0.0001).

Figure 3

Histogram of degree of amblyopia of the worse eye at baseline for early and late surgery group There are no statistically significant or clinically relevant differences in degree of amblyopia between the groups.

Figure 4

Histogram of limitation of abduction of the worse eye at baseline for early and late surgery group There are no statistically significant or clinically relevant differences in the limitation of abduction between the groups.