ArticleMedical devices (Auckland, N.Z.)2022
Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery.
Article in Medical devices (Auckland, N.Z.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04702802 (Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used as a Device During Phacoemulsification and Intraocular Lens Implantation in Patients With Age-related Cataract, Compared to Healon® EndoCoat.), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used as a Device During Phacoemulsification and Intraocular Lens Implantation in Patients With Age-related Cataract, Compared to Healon® EndoCoat.
Who cites it
2 citing papers in PubMed.
- Randomized comparative multicenter study assessing two dispersive viscosurgical devices for cataract surgery.Journal of cataract and refractive surgery · 2026Trial
- Physical Characteristics, Clinical Application, and Side Effects of Viscoelastics in Ophthalmology.Journal of current ophthalmologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
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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