Saenz Bobby, Ferguson Tanner J, Abraham Noelle, Mueller Brett H, Parkhurst Gregory D
Parkhurst NuVision, San Antonio, TX, USA.
Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA.
Clin Ophthalmol. 2021 Dec 7;15:4615-4620. doi: 10.2147/OPTH.S334297. eCollection 2021.
To evaluate the safety and efficacy of a sustained-release intracanalicular dexamethasone insert for postoperative inflammation and pain implanted in a clinical setting preoperatively or on postoperative day 1.
Single-site, retrospective, contralateral eye study of patients undergoing cataract surgery. Included were subjects with a dexamethasone intracanalicular insert implanted in the clinic immediately prior to surgery in one eye (same-day) and on postoperative day 1 (POD1) in the contralateral eye. The primary outcome measure was the resolution of anterior chamber inflammation at 1 week postoperative. Secondary outcome measures included proportion of eyes requiring additional therapy for pain and inflammation through 1 month as well as the number of eyes with IOP spikes above baseline. Safety measures included adverse events through 1 month postoperative.
Sixty-two eyes of 31 subjects were included in the case series. At 1 week postoperative, 52% of the eyes (n = 16) achieved complete resolution of inflammation in the same-day group and 58% (n = 18) met this endpoint at 1 week in the POD1 group. One subject in the same-day group required additional therapy for rebound inflammation and no eyes required additional therapy in the POD1 group. There were no reports of pain at 1 week or 1 month in either group. There were no implant-related adverse events in either group.
The favorable results of this study indicate that the sustained-release dexamethasone insert can be safely implanted in the clinic either preoperatively on the day of surgery or on postoperative day 1 for the control of pain and inflammation following cataract surgery.
评估术前或术后第1天在临床环境中植入的缓释型房水内曲安奈德插入物对术后炎症和疼痛的安全性和有效性。
对接受白内障手术的患者进行单中心、回顾性、对侧眼研究。纳入的受试者中,一只眼在手术当天(同一天)于临床立即植入房水内曲安奈德插入物,对侧眼在术后第1天(POD1)植入。主要结局指标是术后1周前房炎症的消退情况。次要结局指标包括至术后1个月需要额外治疗疼痛和炎症的眼的比例以及眼压高于基线的眼的数量。安全性指标包括术后1个月内的不良事件。
该病例系列纳入了31名受试者的62只眼。术后1周时,同一天组52%的眼(n = 16)炎症完全消退,POD1组在术后1周时58%(n = 18)达到这一终点。同一天组有1名受试者因炎症反弹需要额外治疗,POD1组无眼需要额外治疗。两组在术后1周或1个月时均无疼痛报告。两组均无与植入物相关的不良事件。
本研究的良好结果表明,缓释型曲安奈德插入物可在手术当天术前或术后第1天在临床安全植入,以控制白内障手术后的疼痛和炎症。