Orbit and Oculoplasty Services, Narayana Nethralaya, Bengaluru, Karnataka, India.
Indian J Ophthalmol. 2019 Jul;67(7):1148-1151. doi: 10.4103/ijo.IJO_1813_18.
The study aims to analyze risk factors for exposure of orbital implants after evisceration by comparison of patients with and without exposure of implants.
This is a case control study in retrospective interventional case series; Group A- implant exposures after evisceration, Group B - Patients on follow up after evisceration with implant, without exposure, with matched duration of follow up. The sample size is calculated for a power of 80.
Group A comprised 32 sockets with implant exposure, presenting at median 18 months after surgery; Group B included 61 eviscerated sockets, without implant exposure, with follow up median 36 months. Odds Ratio (OR) was calculated; infected eyes -OR 1.3, P = 0.6; phthisical eye - OR 1.4, P = 0.43; multiple prior surgeries- OR 1.55, P = 0.33. Group A had 59.3% porous implants, Group B 55.7%, - OR 1.3, P = 0.5. Mean implant size in Group A 19.06 mm, Group B 18.78 mm- showed no statistical difference. Multiple logistic regression analysis showed no significant risk factor for exposure. Surgeon factor was not analyzed since there were multiple surgeons.
This is the first study with calculated sample size, comparing implant exposure patients to a control group. Porous implant material, presence of infection, phthisical scleral shell, and prior surgery showed higher trend of exposure (Odds ratio >1), but none was conclusive. Larger size of implant was not a risk factor for exposure. Eliminating the role of several factors in implant exposure allows the surgeon to make better surgical choices: such as place an implant of appropriate size, of a material of surgeon's choice, and do primary placement of implant in a patient with evisceration post-corneal ulcer or endophthalmitis. A hypothesis and a recommendation is that meticulous attention be paid to surgical technique.
本研究旨在通过比较眼球摘除术后发生和未发生眶内植入物暴露的患者,分析发生植入物暴露的危险因素。
这是一项回顾性干预性病例系列的病例对照研究;A 组 - 眼球摘除术后植入物暴露,B 组 - 眼球摘除术后植入物未暴露,随访时间匹配。样本量计算为 80%的功效。
A 组有 32 个植入物暴露的眼窝,中位随访时间为术后 18 个月;B 组有 61 个未暴露植入物的眼窝,中位随访时间为 36 个月。计算了比值比(OR);感染眼 -OR 1.3,P = 0.6;葡萄膜炎眼 -OR 1.4,P = 0.43;多次既往手术 -OR 1.55,P = 0.33。A 组多孔植入物占 59.3%,B 组占 55.7% - OR 1.3,P = 0.5。A 组植入物平均大小为 19.06mm,B 组为 18.78mm- 无统计学差异。多因素逻辑回归分析未发现明显的暴露危险因素。由于有多位外科医生参与手术,因此未对手术医生因素进行分析。
这是第一项使用计算样本量的研究,比较了植入物暴露患者和对照组。多孔植入物材料、感染、葡萄膜炎巩膜壳和既往手术显示出更高的暴露趋势(比值比>1),但均无定论。植入物尺寸较大不是暴露的危险因素。消除植入物暴露的多个因素的作用可以让外科医生做出更好的手术选择:例如,在角膜溃疡或眼内炎后行眼球摘除术的患者中,放置大小合适、外科医生选择材料的植入物,并进行初次植入。有一个假设和建议是,手术技术需要格外注意。