Bilateral medial rectus recession with or without posterior fixation in large-angle infantile esotropia: a randomized controlled trial.

Purpose: To compare the results of bilateral medial rectus recession (BMRc) versus bilateral medial rectus recession with Faden operation (BMRF) in the treatment of large-angle infantile esotropia.

Study design: A double blinded, parallel, randomized controlled trial.

Methods: Patients with large-angle infantile esotropia (≥ 60 prism diopters, [PD]) aged between 3 and 15 years old were included and assigned to either the BMRc or BMRF group. Mean difference and mean reduction of angle deviation between the two groups were compared at 1 week, 1, 3, and 6 months by using generalized estimating equations analysis. Surgical success rates, defined as an esodeviation ≤ 10 PD at near fixation, were evaluated at 6 months postoperatively. Complications from the surgical procedures were observed.

Results: Of 40 enrolled patients, the mean (SD) age of the patients in the BMRc group was 3.4 (1.9), and in the BMRF group, 5.2 (3.8) years old. The overall mean differences of angle reduction between both groups were not significant (-6 PD, 95%CI -14 to 2, P = .12). The surgical success rate at 6 months in the BMRF group (72%) was not different compared to BMRc group (84%, P = .45). Overall consecutive exotropia was 5%, not different between groups (P > .99). There was no difference of complications between the two groups (P = .51).

Conclusion: BMRF and BMRc approaches show no difference in treatment of large-angle infantile esotropia. Nevertheless, a long-term assessment for consecutive exotropia should be considered for both surgical procedures.