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

i+Med S.Coop.

Status: Completed

Conditions: Cataract Surgery

Treatments: Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07343973

OpHLINE-PIC01-2020

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or older scheduled for cataract extraction by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye (operative eye).
• The non-operative eye must be functional, as assessed by the investigator.

Exclusion criteria

• Ocular hypertension (IOP ≥ 22 mmHg).
• Corneal endothelial damage (cell count < 2000 cells/mm²).
• History of chronic or recurrent ocular inflammatory disease.
• Chronic or recurrent uveitis.
• Acute ocular disease.
• Internal or external ocular infection.
• Glaucoma or proliferative diabetic retinopathy.
• Previous ocular trauma before surgery.
• Congenital ocular anomalies or iris atrophy.
• Any other ocular pathology or physiological condition that could be worsened by cataract surgery.
• Previous ocular surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups

OpHLINE® 1.4%

Experimental group

Description:

Patients undergoing cataract surgery received the OpHLINE OVD with 1.4% sodium hyaluronate. This formulation is designed to maintain the anterior chamber space and protect corneal endothelial cells while offering easier removal due to its lower viscosity.

Treatment:

Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation

OpHLINE® 2%

Experimental group

Description:

Patients in this group were treated with the OpHLINE OVD containing 2% sodium hyaluronate. This intermediate concentration aims to provide enhanced space stability during surgical phases while balancing protection and handling characteristics.

Treatment:

Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation

OpHLINE® 3%

Experimental group

Description:

This group received the OpHLINE OVD with 3% sodium hyaluronate, the highest concentration tested. It is intended to maximize space maintenance and tissue protection during surgery, though it may require more effort for removal due to its higher viscosity.

Treatment:

Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation