Medical Devices: Evidence and Research (Aug 2022)

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

  • Palacio-Pastrana C,
  • Muñoz-Villegas P,
  • Dániel-Dorantes F,
  • Sánchez-Ríos A,
  • Olvera-Montaño O,
  • Martínez-Montoya YI,
  • Quintana-Hau JD,
  • Baiza-Durán LM

Journal volume & issue
Vol. Volume 15
pp. 293 – 305

Abstract

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Claudia Palacio-Pastrana,1 Patricia Muñoz-Villegas,2 Fernando Dániel-Dorantes,3 Alejandra Sánchez-Ríos,2 Oscar Olvera-Montaño,2 Yareni I Martínez-Montoya,1 Juan D Quintana-Hau,3 Leopoldo M Baiza-Durán2 1SalaUno Salud, SAPI de CV, México City, México; 2Regional Medical Affairs Department, Laboratorios Sophia SA de CV, Zapopan, Jalisco, México; 3Research and Development Department (CIS), Zapopan, Jalisco, MéxicoCorrespondence: Patricia Muñoz-Villegas, Laboratorios Sophia, SA de CV, Paseo del Norte 5255, Guadalajara Technology Park, Zapopan, Jalisco, 45010, México, Tel +52 3301 4200, Ext: 1018, Email [email protected]: 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).Keywords: rheology, sodium hyaluronate, surgical procedure, viscoadaptative, viscosity

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