Clinical Investigation of IXIUM TWIN Viscoelastic Ophthalmic Device For Cataract Surgery (IXIUM_TWIN)

Randomized Clinical Investigation Of The IXIUM TWIN Viscoelastic Ophthalmic Device (OVD) For Cataract Surgery With Intraocular Lens Implantation

This clinical trial is testing a new surgical gel called IXIUM TWIN, designed to protect the eye during cataract surgery. Cataracts, which cloud the eye's natural lens, are the leading cause of vision loss worldwide. Surgery to remove the cataract and replace it with an artificial lens is the standard treatment, and viscoelastic gels like IXIUM TWIN are used to keep the eye stable and safe during the procedure.

The goal of this study is to compare IXIUM TWIN with an already approved gel (HEALON) to ensure it works just as well (or better) in protecting the delicate cells inside the eye. Specifically, researchers will measure whether IXIUM TWIN causes less damage to the eye's inner lining (endothelial cells) after surgery.

Who can take part? Adults aged 18 and older who have cataracts and are scheduled for surgery may qualify. Only one eye per participant will be included. Patients must be able to attend follow-up visits and provide informed consent.

What does participation involve? Before surgery, participants will have eye exams to check vision, cell health, corneal thickness, and eye pressure. During surgery, they will randomly receive either IXIUM TWIN or HEALON (neither the patient nor the surgeon will choose). After surgery, follow-up visits at 1 day, 7 days, 30 days, and 90 days will monitor healing, vision improvement, and any side effects.

Potential risks and benefits As with any cataract surgery, there are minor risks, such as temporary increased eye pressure, inflammation, or swelling, but these are rare and usually resolve quickly. The benefits include improved vision after cataract removal. If successful, IXIUM TWIN could offer surgeons another high-quality option for protecting the eye during surgery.

Study timeline Patient enrollment begins in January 2025 and ends in June 2025, with follow-ups completing by September 2025. The full study is expected to conclude in early 2026.

This study is sponsored by LCA Pharmaceutical and will take place at four hospitals in France. Participation is voluntary, and patients can withdraw at any time.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract Surgery
• Intervention / Treatment: Device: IXIUM TWIN; Device: HEALON

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrice VINCENT; Phone Number: 02 37 33 39 30; Email: pvincent@lca-pharma.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adult patients (≥18 years) with cataract (described and coded per WHO classification²⁷)
• One eye per patient enrolled in the clinical investigation (IC)
• Intraocular pressure (IOP) controlled or uncontrolled with treatment
• Cataract extraction via phacoemulsification with implantation of a posterior chamber injectable intraocular lens (IOL) through a small incision
• Signed informed consent from both patient and physician
• Patient capable of understanding the IC procedures and geographically stable
• Patient covered by or eligible for a social security/health insurance system

Exclusion Criteria:

• Patient unable to participate in a clinical investigation (IC)
• Pregnant women or those at risk of pregnancy during the study
• Patient under legal guardianship (tutelle), conservatorship (curatelle), or judicial protection (sauvegarde de justice)
• Patient currently enrolled in another clinical investigation at the time of inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IXIUM TWIN; IXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery	Device: IXIUM TWIN; Use of IXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgery
Active Comparator: HEALON; HEALON as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery	Device: HEALON; Use of HEALON as the Ophthalmic Viscosurgical Devices in the cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Endothelial Cell Loss between pre- and post-operative periods	The primary outcome measure is the percentage of endothelial cell loss observed between the pre-operative and post-operative periods during cataract surgery using viscoelastic devices (OVDs). The study assumes that the percentage of endothelial cell loss after using IXIUM TWIN is not clinically worse than that seen with the comparator HEALON, with a non-inferiority margin set at -15%.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with intraocular pressure (IOP) ≥30 mmHg	Proportion of patients with intraocular pressure (IOP) ≥30 mmHg at each visit.	90 days
Slit-lamp biomicroscopy	Slit-lamp biomicroscopy at each visit: Multicriteria evaluation graded (1+ to 4+) per the Standardization of Uveitis Nomenclature (SUN) Working Group classification: Corneal edema: Mild (grade 1+), moderate (grade 2+), severe (grade 3+); Corneal opacity (% surface area): ≤25% (grade 1+), 26-50% (grade 2+), ≥51% (grade 3+); Iritis syndrome: Iris involvement only (grade 1+), iridocyclitis (grade 2+), diffuse anterior chamber (AC) involvement (grade 3+); Inflammatory cells in 1×1 mm field: 6-15 (grade 1+), 16-25 (grade 2+), 26-50 (grade 3+), >50 (grade 4+); Anterior chamber flare: Mild (grade 1+), clear details (grade 2+), hazy details (grade 3+), intense with fibrin (grade 4+)	90 days
Pachymetry	Measurement of corneal thickness	90 days
Best-corrected visual acuity (BCVA) for distance and near vision	Best-corrected visual acuity (BCVA) for distance and near vision at Day 7, 30, and 90 (uncorrected at Day 1).	90 days
Assessment of the viscoelastic device (DM) behavior	Assessment of the viscoelastic device (DM) behavior at each surgical step, distinguishing between the two phases: dispersive and cohesive (Likert scale).	Post-op
Patient satisfaction assessment regarding the procedure (Likert scale)	Patient satisfaction assessment regarding the procedure (Likert scale). Very satisfying - Satisfying - Acceptable - Insufficient	90 days
Assessment of adverse events	Assessment of adverse events at all visits	90 days

Collaborators and Investigators

• Sponsor: LCA Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-A01718-39 (Other Identifier: ANSM)

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