Department of Medicine and Health Sciences "Vincenzo Tiberio", University of Molise, Campobasso, Italy.
"Villa Dei Fiori" Hospital, Acerra, Naples, Italy.
Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):247-253. doi: 10.1007/s00417-021-05345-3. Epub 2021 Aug 18.
This study aims to investigate the safety and efficacy of short-term treatment for ocular surface disease (OSD) with topical low-dose (1,005 mg) preservative-free hydrocortisone in one hundred patients with and without glaucoma.
This was an open label non-randomized clinical trial. Patients with OSD with and without primary open-angle glaucoma (POAG) received topical low-dose (1,005 mg) preservative-free hydrocortisone twice daily in each eye for 2 weeks. All patients underwent a complete ophthalmological examination at baseline (T0) and at 1 (T1) and 2 (T2) weeks post-treatment. At each visit, the intraocular pressure (IOP) and the ocular surface disease index (OSDI) questionnaire scores were recorded; the Schirmer test was performed only at T0 and T2.
The OSDI score significantly decreased in both the POAG and no-POAG groups (both p < 0.0001) after hydrocortisone treatment, with no difference between the two groups (p = 0.72). There were no significant differences in IOP and Schirmer test results between T0 and T2 in both treatment groups (p = 0.68 and p = 0.83, respectively).
Topical low-dose (1,005 mg) preservative-free hydrocortisone is safe and effective for improving OSD symptoms both in patients with and without POAG.
The trial was registered at clinicaltrials.gov under NCT04536129 on 01/09/2020 ("retrospectively registered").
本研究旨在探讨短期局部应用低剂量(1005 毫克)无防腐剂氢可酮治疗伴有或不伴有开角型青光眼(POAG)的眼表疾病(OSD)的安全性和有效性。
这是一项开放标签、非随机的临床试验。伴有或不伴有原发性开角型青光眼(POAG)的 OSD 患者每天每只眼接受两次局部应用低剂量(1005 毫克)无防腐剂氢可酮治疗,共 2 周。所有患者在基线(T0)和治疗后 1 周(T1)和 2 周(T2)时均接受全面眼科检查。每次就诊时,记录眼内压(IOP)和眼表疾病指数(OSDI)问卷评分;仅在 T0 和 T2 时进行 Schirmer 试验。
在 POAG 和非 POAG 组中,OSDI 评分在应用氢可酮治疗后均显著降低(两组均 p<0.0001),两组间无差异(p=0.72)。在两个治疗组中,T0 与 T2 时的 IOP 和 Schirmer 试验结果均无显著差异(p=0.68 和 p=0.83,分别)。
局部应用低剂量(1005 毫克)无防腐剂氢可酮治疗对伴有和不伴有 POAG 的 OSD 患者的 OSD 症状均安全且有效。
该试验于 2020 年 9 月 1 日在 clinicaltrials.gov 上注册为 NCT04536129(“回溯性注册”)。