Extra Ocular Muscle Fenestration as a Weakening Maneuver for Surgical Management of Strabismus: A Randomized Pilot Clinical Trial.

PURPOSE: This study aimed to evaluate the efficacy and safety of fenestration in comparison to the classic muscle recession as a weakening maneuver to horizontal and vertical extra ocular muscles in the surgical management of strabismus.

PATIENTS AND

METHODS

This is a pilot single blind parallel group randomized controlled trial with 1:1 allocation ratio. Male or female patients aged 1- to 60-years-old who were admitted to the Pediatric Ophthalmology and Strabismus Department for surgical correction of horizontal or vertical strabismus. Patients were randomly allocated by the envelop method to either group 1 (muscle fenestration, N=9) or group 2 (classic muscle recession, N=9). All participants were assessed at the first post operative day, at one week, and one month after the surgery for the outcomes.

RESULTS

Postoperative ocular alignment evaluated at the first day, one week, and one month following the operation showed comparable results with no significant differences between both groups (p>0.05). The median postoperative pain score evaluated at the first day following the operation was significantly higher in fenestration group than recession group (the medians were 2.0 and 1.0, respectively, p=0.014). Alternatively, the medians of the pain score were equal in both groups at one week and one month postoperatively (p>0.999). One patient in the fenestration group developed progressive subconjunctival hemorrhage. In contrast, there was no postoperative complications in the recession group (p>0.999).

CONCLUSION

Efficacy and safety of muscle fenestration for correcting horizontal or vertical strabismus was comparable to the classic muscle recession.