Fischinger Isaak, Tetz Manfred, Odame Angela, Kulas Heidi, Abel Martin
Augentagesklinik Spreebogen Berlin, Alt-Moabit 101B, 10557, Berlin, Germany.
Lohmann & Rauscher GmbH & Co. KG, Irlicher Strasse 55, 56567, Neuwied, Rhineland-Palatinate, Germany.
Ophthalmol Ther. 2025 Apr;14(4):659-673. doi: 10.1007/s40123-025-01107-0. Epub 2025 Feb 15.
Ocular sticks are used to absorb fluids during ophthalmic surgeries. Hence, this prospective study was conducted to evaluate the clinical performance, safety, and usability of Pro-optha Ocular Sticks in comparison to an alternative device under the conditions of routine ophthalmic surgeries.
Patients requiring eye surgery were randomly allocated into two equal groups, with the investigational device, Pro-ophta Ocular Sticks, as the intervention group (IG) and the alternative stick as the comparator group (CG). Two types of surgery were performed. The study is also registered on the German Clinical Trials Register with ID DRKS00025690.
106 patients were included in the analyses. In both treatment groups, the investigator's/surgeon's general user satisfaction was rated as either "good" or "very good." The non-inferiority hypothesis that the Pro-ophta Ocular Stick is not rated worse in satisfaction than the alternative device was confirmed with statistical significance (p = 0.0005). At least 98.12% were rated as "good" and "very good" in both treatment groups for the additional endpoints. Pro-ophta Ocular Stick was rated better for almost all the additional endpoints and within the surgery subgroups. The mean number of sticks and surgery duration were 3.5 ± 2.74 and 11.5 (± 8.88) min, respectively, with a positive correlation (r = 0.580) for the Pro-ophta Ocular Stick and 3.9 ± 2.45 and 9.5 (± 5.90) min, respectively, with a positive correlation (r = 0.025) for the alternative device. No device-related adverse events occurred.
Effective ocular sticks play an instrumental role in the outcome of ophthalmic surgeries. The investigational device demonstrated efficiency, yielding good surgical results, usability, and an exceptionally good safety profile.
眼科手术中使用眼用棒来吸收液体。因此，本前瞻性研究旨在评估在常规眼科手术条件下，与另一种器械相比，Pro-optha眼用棒的临床性能、安全性和易用性。
需要眼科手术的患者被随机分为两组，干预组（IG）使用研究器械Pro-optha眼用棒，对照组（CG）使用另一种眼用棒。进行了两种类型的手术。该研究也已在德国临床试验注册中心注册，注册号为DRKS00025690。
106名患者纳入分析。在两个治疗组中，研究者/外科医生的总体用户满意度均被评为“良好”或“非常好”。Pro-optha眼用棒在满意度方面不比另一种器械差的非劣效性假设得到统计学显著性证实（p = 0.0005）。在两个治疗组中，至少98.12%的附加终点被评为“良好”和“非常好”。Pro-optha眼用棒在几乎所有附加终点以及手术亚组中评分更高。Pro-optha眼用棒的平均使用棒数和手术持续时间分别为3.5 ± 2.74根和11.5（± 8.88）分钟，二者呈正相关（r = 0.580），另一种器械的平均使用棒数和手术持续时间分别为3.9 ± 2.45根和9.5（± 5.90）分钟，二者呈正相关（r = 0.025）。未发生与器械相关的不良事件。
有效的眼用棒在眼科手术结果中发挥着重要作用。研究器械显示出有效性，产生了良好的手术效果、易用性以及非常好的安全性。
