Introduction: Effective surgical access to the orbital floor facilitates surgery and mitigates postoperative complications (PC). The aim of this study was to compare PC between the preseptal and retroseptal transconjunctival approaches (PS-TCA/RS-TCA) for isolated orbital floor fracture (OFF).
Materials and Methods: Using a double-blind, non-inferiority, randomized, split-face study design, patients aged ≥ 18 years with bilateral isolated OFF were enrolled. A sample size of 177 eyes per group was determined through power analysis. The primary predictor variable was the surgical approach, and the main outcome was the PC rate at month 6. Statistical analyses were computed with a significance level at 0.05 and the non-inferiority margin at a relative risk (RR) of 0.045.
Results: The final sample included 193 patients (23.3% female; age, 42.8±18.1 years). Both TCA variants exhibited comparable PC rates (5.2% for PS-TCA vs. 7.3% for RS-TCA; P = 0.53; absolute risk, +2.07% [95% CI, -2.74% to 6.89%]; RR, 1.4 [95% CI, 0.64 to 3.07]). Approximately one in every 49 patients experiencing PC with RS-TCA (number needed to harm, 48.3).
Conclusions: Both TCA methods can be used without different PC rates at 6 months postoperatively. Future research should focus on TCA in combination with other surgical approaches for multiple orbital wall reconstruction.
Competing Interests: Declaration of competing interest The authors have no relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. The authors confirm full freedom in conducting this investigation and preparing the manuscript.
(Copyright © 2024. Published by Elsevier Masson SAS.)