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

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, 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

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).

Keywords: rheology; sodium hyaluronate; surgical procedure; viscoadaptative; viscosity.

Conflict of interest statement

The funder provided support in the form of salaries for authors [PMV, ASR, OOM, and LBD], but this commercial affiliation did not have any additional role in the data collection. The rest of the authors declared that they had no personal, financial, commercial, or academic interest.

© 2022 Palacio-Pastrana et al.

Figures

Figure 1
Figure 1
Shear rate (s−1) versus average viscosity (Pascal second) for test OVD (PRO-149) compared to control OVD (HEC) in logarithmic scale. Data from 3 batches.
Figure 2
Figure 2
Changes in intraocular pressure (Delta-IOP), mmHg measurements in aqueous humor exchange rabbit model (A) and anterior chamber washout rabbit model (B). No statistically significant differences were found between HEC (control) and PRO-149 (test), p>0.05 in all comparisons.
Figure 3
Figure 3
Changes in intraocular pressure (Delta-IOP), mmHg (A), and changes in best corrected visual acuity (BCVA) in Snellen fraction (B), after phacoemulsification and lens implantation in PP population. No statistically significant differences were found between HEC (control) and PRO-149 (test), p>0.05 in all comparisons.
Figure 4
Figure 4
Rate of the overall clinical performance of the HEC (control) and PRO-149 (test). The items were scored as “acceptable” to “very good” in all cases for both OVDs. For “Ease of use during extraction/removal” PRO-149 > HEC, p=0.044.

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Source: PubMed

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