Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery.

IF 1.3 Q4 ENGINEERING, BIOMEDICAL

Medical Devices-Evidence and Research Pub Date : 2022-08-24 eCollection Date: 2022-01-01 DOI:10.2147/MDER.S379050

Claudia Palacio-Pastrana, Patricia Muñoz-Villegas, Fernando Dániel-Dorantes, Alejandra Sánchez-Ríos, Oscar Olvera-Montaño, Yareni I Martínez-Montoya, Juan D Quintana-Hau, Leopoldo M Baiza-Durán

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Abstract

Purpose: To evaluate the rheological properties of the ophthalmic viscoelastic device (OVD) PRO-149, its preclinical safety, and its effectiveness when used during cataract surgery in patients with age-related cataract.

Material and methods: Control (HEC) and test (PRO-149) OVDs were compared through rheological measures, by two preclinical safety studies in rabbits, and under normal-use conditions during cataract removal and lens implantation in a parallel randomized clinical trial.

Results: Rheological properties were determined. Preclinical studies did not find any evidence of safety issues or toxicity. In the clinical trial, 36 subjects were included. After 29 days, there were no statistically significant differences in mean percentage of endothelial cell count change or in the postoperative intraocular pressure between groups. There were no significant differences between OVDs for any safety parameter studied. Finally, PRO-149 showed a statistically significant improvement in surgeon rating for ease of use during extraction (p < 0.05).

Conclusion: PRO-149 is a dispersive OVD. The rabbit models did not find evidence of clinical alterations or toxicity. The results of the clinical study support that the two studied OVDs were clinically similar in terms of safety and effectiveness for cataract surgery.

Trial registration: The trial is registered at Clinical Trials.gov at NCT04702802 (21-01-11).

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一种用于白内障手术的新型分散性眼粘弹性装置的流变学特性、临床前安全性和临床有效性评估。

目的:评价眼粘弹性装置(OVD) PRO-149的流变性能、临床前安全性以及在老年性白内障手术中的应用效果。材料与方法:对照(HEC)和试验(PRO-149) ovd通过流变学指标、两项家兔临床前安全性研究以及在白内障摘除和晶状体植入术中正常使用条件下的平行随机临床试验进行比较。结果:测定了其流变性能。临床前研究没有发现任何安全问题或毒性的证据。临床试验共纳入36名受试者。29天后，两组间内皮细胞计数改变的平均百分比和术后眼压的差异均无统计学意义。在研究的任何安全参数中，ovd之间没有显著差异。最后，PRO-149在拔牙过程中易用性的外科医生评分上有统计学意义的改善(p < 0.05)。结论:PRO-149是一种弥散性OVD。兔模型未发现临床改变或毒性的证据。临床研究结果支持两种ovd在白内障手术的安全性和有效性方面具有临床相似性。试验注册:该试验已在Clinical Trials.gov注册，注册号为NCT04702802(21-01-11)。

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