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Clinical Investigation of IXIUM TWIN Viscoelastic Ophthalmic Device For Cataract Surgery

ConditionCataract Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLCA Pharmaceutical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • IXIUM TWIN

    Device

    Use of IXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgery

  • HEALON

    Device

    Use of HEALON as the Ophthalmic Viscosurgical Devices in the cataract surgery

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: IXIUM TWINExperimental treatment 1 intervention
Group B: HEALONActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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%.

Time frame
90 days

Secondary outcomes

1

Proportion of patients with intraocular pressure (IOP) ≥30 mmHg

Proportion of patients with intraocular pressure (IOP) ≥30 mmHg at each visit.

Time frame
90 days
2

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+)

Time frame
90 days
3

Pachymetry

Measurement of corneal thickness

Time frame
90 days
4

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).

Time frame
90 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LCA Pharmaceutical

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: