NCT07343973

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

Post-Market Study for the Evaluation of the Efficacy and Safety of the OpHLINE Ophthalmic Viscosurgical Device (OVD) in Cataract Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: i+Med S.Coop. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cataract Surgery

Interventions

Type	Name	Description
DEVICE	Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%)	Eligible patients underwent cataract removal by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye. The surgical procedure included the following steps: Capsulorhexis: creation of a continuous circular opening in the anterior capsule of the lens. Hydrodissection: injection of fluid to separate the capsule from the cortex. Phacoemulsification: ultrasonic fragmentation and aspiration of the opacified lens through a micro-incision. IOL insertion: placement of the intraocular lens in the posterior chamber. OpHLINE 1.4% OVD was used as an adjunct during these phases to maintain the anterior chamber space and protect ocular tissues. After lens implantation, the viscoelastic device were aspirated according to standard surgical practice.
DEVICE	Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%)	Eligible patients underwent cataract removal by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye. The surgical procedure included the following steps: Capsulorhexis: creation of a continuous circular opening in the anterior capsule of the lens. Hydrodissection: injection of fluid to separate the capsule from the cortex. Phacoemulsification: ultrasonic fragmentation and aspiration of the opacified lens through a micro-incision. IOL insertion: placement of the intraocular lens in the posterior chamber. OpHLINE 2% OVD was used as an adjunct during these phases to maintain the anterior chamber space and protect ocular tissues. After lens implantation, the viscoelastic device were aspirated according to standard surgical practice.
DEVICE	Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%)	Eligible patients underwent cataract removal by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye. The surgical procedure included the following steps: Capsulorhexis: creation of a continuous circular opening in the anterior capsule of the lens. Hydrodissection: injection of fluid to separate the capsule from the cortex. Phacoemulsification: ultrasonic fragmentation and aspiration of the opacified lens through a micro-incision. IOL insertion: placement of the intraocular lens in the posterior chamber. OpHLINE 3% OVD was used as an adjunct during these phases to maintain the anterior chamber space and protect ocular tissues. After lens implantation, the viscoelastic device were aspirated according to standard surgical practice.

Timeline

• Start date: 2021-03-02
• Primary completion: 2022-09-14
• Completion: 2022-09-14
• First posted: 2026-01-15
• Last updated: 2026-02-11

Locations

2 sites across 1 country: Spain