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The Effectiveness and Safety of Dextenza 0.4 mg for the Treatment of Postoperative Inflammation and Pain in Patients After Photorefractive Keratectomy: The RESTORE Trial.
Journal of Refractive Surgery ( IF 2.9 ) Pub Date : 2021-09-01 , DOI: 10.3928/1081597x-20210610-05
Mitchel J. Ibach , Brian M. Shafer , Doug D. Wallin , Keeley R. Puls-Boever , Vance M. Thompson , John P. Berdahl

PURPOSE To determine patient preference and treatment outcomes with an intracanalicular dexamethasone 0.4 mg insert compared to a standard steroid drop regimen in the contralateral eye following bilateral photorefractive keratectomy (PRK). METHODS In this randomized, prospective, self-controlled, open-label interventional study, one eye received the dexamethasone insert and the second eye received prednisolone acetate 1% taper following bilateral PRK surgery. Postoperative evaluations were performed on day 3, day 4, month 1, and month 3. Phone call surveys were performed on week 2. The Comparison of Ophthalmic Medications for Tolerability questionnaire was used to determine patient preference between postoperative regimens and postoperative pain. Corneal endpoints included time to epithelialization, presence of corneal haze, sodium fluorescein staining, and modified Standardized Patient Evaluation of Eye Dryness (SPEED) scores. Both corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were assessed. RESULTS Twenty patients participated in the study. At month 3, 70% of patients preferred the dexamethasone insert, 20% preferred prednisolone acetate, and 10% expressed no preference. Patient surveys did not show a difference in postoperative pain between the study group and control group. No statistical difference was shown in time to epithelialization, 90-day CDVA or UDVA, postoperative corneal haze, corneal staining, or modified SPEED scores. CONCLUSIONS In patients undergoing PRK, there was preference toward a dexamethasone insert in place of topical prednisolone acetate for the postoperative steroid treatment. There were no statistically or clinically significant differences between the two cohorts in regard to healing time or visual outcomes. [J Refract Surg. 2021;37(9):590-594.].

中文翻译:

Dextenza 0.4 mg 用于治疗屈光性角膜切除术后患者术后炎症和疼痛的有效性和安全性:RESTORE 试验。

目的 与双侧屈光性角膜切除术 (PRK) 后对侧眼中使用 0.4 毫克小管内注射地塞米松与标准类固醇滴剂方案相比,确定患者的偏好和治疗结果。方法在这项随机、前瞻性、自我对照、开放标签的干预研究中,一只眼睛在双侧 PRK 手术后接受地塞米松插入物,第二只眼睛接受醋酸泼尼松龙 1% 锥度。在第 3 天、第 4 天、第 1 个月和第 3 个月进行术后评估。在第 2 周进行电话调查。使用眼科药物耐受性问卷比较来确定患者对术后方案和术后疼痛的偏好。角膜终点包括上皮形成时间、角膜混浊的存在、荧光素钠染色和改良的标准患者眼干评估 (SPEED) 评分。对矫正远视力 (CDVA) 和未矫正远视力 (UDVA) 进行了评估。结果 20 名患者参加了这项研究。在第 3 个月,70% 的患者更喜欢地塞米松插入物,20% 的患者更喜欢醋酸泼尼松龙,10% 的患者表示不喜欢。患者调查未显示研究组和对照组在术后疼痛方面存在差异。在上皮形成时间、90 天 CDVA 或 UDVA、术后角膜混浊、角膜染色或改良的 SPEED 评分方面没有显示出统计学差异。结论 在接受 PRK 的患者中,术后类固醇治疗更倾向于使用地塞米松插入物代替局部醋酸泼尼松龙。两个队列在愈合时间或视力结果方面没有统计学或临床上的显着差异。[J 屈光手术。2021;37(9):590-594.]。
更新日期:2021-09-01
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