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

NCT ID: NCT07343973

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2022-09-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OpHLINE® 1.4%

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.

Group Type: EXPERIMENTAL

Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation

Intervention Type: DEVICE

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%, 2% and 3% OVD were 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.

OpHLINE® 2%

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.

Group Type: EXPERIMENTAL

Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation

Intervention Type: DEVICE

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%, 2% and 3% OVD were 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.

OpHLINE® 3%

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.

Group Type: EXPERIMENTAL

Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation

Intervention Type: DEVICE

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%, 2% and 3% OVD were 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.

Interventions

Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation

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%, 2% and 3% OVD were 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Araba

OTHER

Sponsor Role: collaborator

Hospital Universitario Basurto

UNKNOWN

Sponsor Role: collaborator

i+Med S.Coop.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Basurto University Hospital

Bilbao, Bizkaia, Spain

Araba University Hospital

Vitoria-Gasteiz, Álava, Spain

Countries

Spain

Other Identifiers

OpHLINE-PIC01-2020

Identifier Type: -

Identifier Source: org_study_id