Department of Medicine and Surgery, Ophthalmology Section, S. Maria Della Misericordia Hospital, University of Perugia, Perugia, Italy.
Ophthalmology Unit, Misericordia Hospital, USL Toscana Sud Est, Grosseto, Italy.
Int Ophthalmol. 2021 Sep;41(9):3065-3071. doi: 10.1007/s10792-021-01869-z. Epub 2021 May 6.
Prospective, randomised, open-label, comparative study to evaluate efficacy of trehalose/sodium hyaluronate eye drops for post-operative discomfort and tear film stability in patients undergoing cataract surgery.
Patients with healthy ocular surface, subclinical, or mild dry eye were enrolled. Tear breakup time (TBUT), Schirmer test, dry eye symptoms, corneal fluorescein staining (CFS), and ocular surface disease (OSDI) evaluation were performed pre-operatively and at two and four weeks after surgery. Patients were assigned to receive trehalose/sodium hyaluronate eye drops b.i.d (Group A), or 0.9% unpreserved sodium chloride eye drops b.i.d for 4 weeks (Group B).
One hundred and thirty-five patients were randomised, 66 patients in Group A (73.2 ± 4.5 years) and 69 patients in Group B (74.3 ± 3.8 years), 60.8% females. Fifteen patients (8 Group A) were lost at follow-up. Pre-operatively, no between-group differences were observed, and TBUT increased in Group A between the pre-operative and 2 and 4 week evaluations and was higher in group A than in Group B at 4 weeks. Schirmer test and CFS showed an improvement only in Group A four weeks post-operatively. In Group A an improvement was observed after two and four weeks in foreign body and puncture sensation, whilst a difference in blinking discomfort was observed after four weeks. In Group B we observed an improvement in puncture sensation two and four weeks after surgery. Mean OSDI scores differences between the two groups were significant at four weeks.
Trehalose/sodium hyaluronate eye drops were effective in reducing signs and symptoms of dry eye and improving tear film stability.
前瞻性、随机、开放标签、对照研究，评估海藻糖/透明质酸钠滴眼液在白内障手术后患者术后不适和泪膜稳定性中的疗效。
纳入具有健康眼表、亚临床或轻度干眼的患者。术前及术后 2 周和 4 周进行泪膜破裂时间（TBUT）、泪液分泌试验、干眼症状、角膜荧光素染色（CFS）和眼表疾病（OSDI）评估。患者被分配接受海藻糖/透明质酸钠滴眼液 b.i.d（A 组）或 0.9%未保存氯化钠滴眼液 b.i.d 治疗 4 周（B 组）。
135 名患者被随机分组，A 组 66 例（73.2±4.5 岁），B 组 69 例（74.3±3.8 岁），女性占 60.8%。15 例患者（8 例 A 组）在随访时失访。术前两组间无差异，A 组 TBUT 在术前与术后 2 周和 4 周评估时增加，且 4 周时高于 B 组。术后 4 周时，A 组 Schirmer 试验和 CFS 显示改善。A 组术后 2 周和 4 周时异物感和刺痛感改善，4 周时眨眼不适有差异。B 组术后 2 周和 4 周时刺痛感改善。术后 4 周两组间 OSDI 评分差异有统计学意义。
海藻糖/透明质酸钠滴眼液可有效减轻干眼症状和体征，改善泪膜稳定性。
