Abstract：
BACKGROUND: 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).
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.
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.
摘要：
背景：有效手术进入眶底可促进手术并减轻术后并发症（PC）。这项研究的目的是比较经结膜前和经结膜后间隔入路（PS-TCA/RS-TCA）治疗孤立性眶底骨折（OFF）的PC。
方法：使用双盲，非自卑，随机化，分面研究设计，纳入年龄≥18岁的双侧隔离OFF患者.通过功率分析确定每组177只眼的样品大小。主要预测变量是手术方法，主要结果是6个月的PC率。统计分析的显著性水平为0.05，相对风险（RR）为0.045的非劣效性界限。
结果：最终样本包括193名患者（23.3％为女性；年龄，42.8±18.1年）。两种TCA变体均表现出可比的PC率（PS-TCA的5.2％与RS-TCA为7.3%；P=0.53；绝对风险，+2.07%[95%CI，-2.74%至6.89%]；RR，1.4[95%CI，0.64至3.07]）。大约每49名患者中就有一名患有RS-TCA的PC(伤害所需的人数，48.3).
结论：两种TCA方法均可在术后6个月无不同PC率的情况下使用。未来的研究应集中在TCA与其他手术方法的结合以进行多个眶壁重建。
方法：使用双盲，非自卑，随机化，分面研究设计，纳入年龄≥18岁的双侧隔离OFF患者.通过功率分析确定每组177只眼的样品大小。主要预测变量是手术方法，主要结果是6个月的PC率。统计分析的显著性水平为0.05，相对风险（RR）为0.045的非劣效性界限。
结果：最终样本包括193名患者（23.3％为女性；年龄，42.8±18.1年）。两种TCA变体均表现出可比的PC率（PS-TCA的5.2％与RS-TCA为7.3%；P=0.53；绝对风险，+2.07%[95%CI，-2.74%至6.89%]；RR，1.4[95%CI，0.64至3.07]）。大约每49名患者中就有一名患有RS-TCA的PC(伤害所需的人数，48.3).
结论：两种TCA方法均可在术后6个月无不同PC率的情况下使用。未来的研究应集中在TCA与其他手术方法的结合以进行多个眶壁重建。
