NCT07343973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 7, 2026

Last Update Submit

February 9, 2026

Conditions

Cataract Surgery

Keywords

Hyaluronic acidOphtalmic viscosurgical deviceCataract surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Assessment of removal difficulty after IOL implantation

    6 hours

  • Percentage of endothelial cell density loss

    90 days

  • Incidence of IOP ≥30 mmHg during follow-up

    90 days

  • Frequency of non-serious adverse events during follow-up

    90 days

Study Arms (3)

OpHLINE® 1.4%

EXPERIMENTAL

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%)

OpHLINE® 2%

EXPERIMENTAL

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%)

OpHLINE® 3%

EXPERIMENTAL

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%)

Interventions

Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%)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% 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.

OpHLINE® 1.4%
Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%)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 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.

OpHLINE® 2%
Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%)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 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.

OpHLINE® 3%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Basurto University Hospital

Bilbao, Bizkaia, 48013, Spain

Location

Araba University Hospital

Vitoria-Gasteiz, Álava, 01009, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

March 2, 2021

Primary Completion

September 14, 2022

Study Completion

September 14, 2022

Last Updated

February 11, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)