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

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.

Study Overview

• Status: Completed
• Conditions: Cataract Surgery
• Intervention / Treatment: Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%); Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%); Device: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%)

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48013
      • Basurto University Hospital
  • Álava
    • Vitoria-Gasteiz, Álava, Spain, 01009
      • Araba University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to maintain anterior chamber space during cataract surgery.	This outcome evaluates whether the OpHLINE OVD can maintain a stable and adequate anterior chamber throughout all critical phases of cataract surgery: capsulorhexis, hydrodissection, phacoemulsification, and intraocular lens (IOL) insertion. Surgeons assessed this parameter using a structured questionnaire, classifying the chamber status into four categories: Complete chamber, Adequate working space, Shallow chamber, and Flat. A positive outcome is defined as achieving either a complete chamber or adequate working space in at least 70% of cases. This measure reflects the core functionality of the OVD in providing surgical safety and facilitating precise maneuvers.	90 days
Safety evaluation of OpHLINE during and after surgery	This measure involves systematic monitoring and documentation of any serious adverse events related to the device during the entire study period. SAEs include any event that could result in significant harm or require medical intervention. The target is an incidence rate of ≤1%, confirming that the device does not introduce unexpected risks beyond those inherent to cataract surgery.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of removal difficulty after IOL implantation	Surgeons classify removal as Easy, Normal, or Problematic. Adequate removal is defined as Easy or Normal in at least 70% of cases	6 hours
Percentage of endothelial cell density loss	Endothelial cell density was measured using a non-contact specular microscope at baseline and at 90 days post-surgery. The goal is to determine the protective effect of the OVD on corneal tissue during surgery. A loss of ≤12% is considered optimal, as excessive cell loss can compromise corneal transparency and visual outcomes.	90 days
Incidence of IOP ≥30 mmHg during follow-up	IOP was measured at all scheduled visits to monitor postoperative pressure changes. The target is ≤13% incidence at 6 hours post-surgery and ≤6% at subsequent visits. Elevated IOP (>30 mmHg) can lead to optic nerve damage if not controlled, so this measure ensures the device does not contribute to clinically significant pressure spikes.	90 days
Frequency of non-serious adverse events during follow-up	This includes any minor complications or events that occur during or after surgery, such as mild inflammation or transient discomfort. The acceptable threshold is ≤30% across the study period, aligning with typical postoperative profiles for cataract surgery.	90 days

Collaborators and Investigators

• Sponsor: i+Med S.Coop.
• Collaborators: Hospital Universitario Araba; Hospital Universitario Basurto

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Actual): September 14, 2022
• Study Completion (Actual): September 14, 2022

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cataract surgery; Hyaluronic acid; Ophtalmic viscosurgical device
• Other Study ID Numbers: OpHLINE-PIC01-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No