Post-Market Study on the Safety and Effectiveness of the OpHLINE OVD in Cataract Surgery

This post-market clinical study was designed to assess the safety and effectiveness of the OpHLINE Ophthalmic Viscosurgical Device (OVD) as an adjunct in cataract surgery. OpHLINE is a sterile, viscoelastic solution based on high-molecular-weight sodium hyaluronate, intended to maintain the anterior chamber space and protect corneal endothelial cells during phacoemulsification and intraocular lens (IOL) implantation. The hypothesis is that OpHLINE, available in three concentrations (1.4%, 2%, and 3%), will provide optimal space maintenance throughout all surgical phases-capsulorhexis, hydrodissection, phacoemulsification, and IOL insertion-while ensuring ease of removal and minimizing postoperative complications. Specifically, the study expects the device to demonstrate high biocompatibility, effective protection of corneal endothelial cells, and a low incidence of adverse events, including intraocular pressure (IOP) spikes. The objectives include confirming compliance with current clinical performance standards and collecting surgeons' feedback on handling and usability. This evaluation aims to strengthen real-world evidence supporting OpHLINE as a safe and reliable solution for cataract surgery, ensuring patient safety and surgical efficiency.

NCT Number	NCT07343973
Lead Sponsor	i+Med S.Coop. Collaborators: Hospital Universitario Araba, Hospital Universitario Basurto
Conditions	Cataract Surgery
Enrollment	69 participants
Start Date	2021-03-02
Primary Completion	2022-09-14 (estimated)
Study Completion	2022-09-14 (estimated)
Updated on ClinicalTrials.gov	2026-02-11