Donnenfeld Eric D, Hovanesian John A, Malik Aysha G, Wong Aidan
Ophthalmic Consultants of Long Island, New York, NY, USA.
Harvard Eye Associates, Laguna Hills, CA, USA.
Clin Ophthalmol. 2023 Aug 15;17:2349-2356. doi: 10.2147/OPTH.S422502. eCollection 2023.
To evaluate clinical efficacy and patient preference for a dropless treatment regimen compared to conventional topical therapy in patients undergoing cataract surgery.
In this prospective, contralateral eye study, patients with bilateral cataract were randomized to receive either intracanalicular dexamethasone insert, intracameral phenylephrine 1%/ketorolac 0.3%, and intracameral moxifloxacin (50 µg) (study group) or topical moxifloxacin 0.5%, ketorolac 0.5%, and prednisolone acetate 1.0% QID (control group). The second eye underwent cataract surgery 2 weeks later and was treated with the opposite treatment. All patients were evaluated at Days 1, 7, 14, 28, and 3 months. The primary outcome measure was postoperative ocular pain. Secondary outcomes included summed ocular inflammation score (SOIS; the sum of the mean anterior chamber cells and anterior flare score), the patient preference for medication protocol between the two eyes, and patient out-of-pocket cost of medications. Safety outcome measures included CDVA, intraocular pressure, central retinal thickness (CRT), and the incidence of reported AEs.
The proportion of patients with no pain was similar in both groups at all postoperative visits (p>0.05). No statistically significant difference in SOIS score was observed between the two groups at any visit. A strong majority of the patients (94.7%) preferred the study eye's dropless regimen over the control eye's conventional topical therapy regimen. No statistically significant difference in mean intraocular pressure (IOP) was observed at any postoperative visit, except at Week 1. The mean CDVA was also similar in both groups at all postoperative visits (p>0.05). The postoperative mean CRT was comparable between the two groups.
A dropless treatment regimen is as effective as topical eyedrop administration. A higher proportion of patients who underwent bilateral cataract surgery preferred the dropless treatment regimen over the patient-administered eye drop regimen.
评估在接受白内障手术的患者中，与传统局部治疗相比，无滴剂治疗方案的临床疗效和患者偏好。
在这项前瞻性对侧眼研究中，双侧白内障患者被随机分为接受管内插入地塞米松、前房内注射1%苯肾上腺素/0.3%酮咯酸和前房内注射莫西沙星（50μg）（研究组）或局部使用0.5%莫西沙星、0.5%酮咯酸和1.0%醋酸泼尼松龙，每日4次（对照组）。第二只眼在2周后接受白内障手术，并接受相反的治疗。所有患者在第1、7、14、28天和3个月时进行评估。主要结局指标是术后眼部疼痛。次要结局包括眼部炎症总分（SOIS；前房细胞平均数和前房闪光评分之和）、患者对两只眼中用药方案的偏好以及患者自付的药物费用。安全性结局指标包括最佳矫正视力（CDVA）、眼压、中心视网膜厚度（CRT）以及报告的不良事件发生率。
在所有术后访视中，两组无痛患者的比例相似（p>0.05）。在任何一次访视中，两组之间的SOIS评分均未观察到统计学上的显著差异。绝大多数患者（94.7%）更喜欢研究眼的无滴剂方案，而不是对照眼的传统局部治疗方案。除第1周外，在任何术后访视中均未观察到平均眼压（IOP）有统计学上的显著差异。两组在所有术后访视中的平均CDVA也相似（p>0.05）。两组术后平均CRT相当。
无滴剂治疗方案与局部滴眼给药同样有效。接受双侧白内障手术的患者中，更高比例的患者更喜欢无滴剂治疗方案，而不是患者自行滴眼的方案。
