Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device.
Journal
Journal of cataract and refractive surgery
ISSN: 1873-4502
Titre abrégé: J Cataract Refract Surg
Pays: United States
ID NLM: 8604171
Informations de publication
Date de publication:
01 08 2023
01 08 2023
Historique:
received:
15
12
2022
accepted:
11
04
2023
medline:
25
7
2023
pubmed:
20
4
2023
entrez:
20
04
2023
Statut:
ppublish
Résumé
To evaluate the safety and effectiveness of a new cohesive ophthalmic viscosurgical device (OVD) (StableVisc) compared with a marketed cohesive OVD (ProVisc) in patients undergoing cataract surgery. 22 sites in the United States. Prospective multicenter controlled double-masked and randomized 1:1 (StableVisc:ProVisc; stratified by site, age group, and cataract severity). Adults (≥45 years) with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens implantation were included. Patients were randomized to receive either StableVisc or ProVisc during standard cataract surgery. Postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety endpoint was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority between the devices was tested. Inflammation and adverse events were evaluated. 390 patients were randomized; 187 patients with StableVisc and 193 patients with ProVisc completed the study. StableVisc was noninferior to ProVisc in mean ECD loss from baseline to 3 months (17.5% and 16.9%, respectively). StableVisc was noninferior to ProVisc in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (5.2% and 8.2%, respectively). The StableVisc cohesive OVD, which provides both mechanical and chemical protection, was safe and effective when used in cataract surgery and provides surgeons with a new cohesive OVD.
Identifiants
pubmed: 37079390
doi: 10.1097/j.jcrs.0000000000001201
pii: 02158034-990000000-00201
doi:
Substances chimiques
Hyaluronic Acid
9004-61-9
Banques de données
ClinicalTrials.gov
['NCT04192630']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
804-811Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of ASCRS and ESCRS.
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