Clinical Investigation of IXIUM TWIN Viscoelastic Ophthalmic Device For Cataract Surgery

NCT ID: NCT07279506

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Cataract Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

IXIUM TWIN

IXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery

Group Type: EXPERIMENTAL

IXIUM TWIN

Intervention Type: DEVICE

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

HEALON

HEALON as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery

Group Type: ACTIVE_COMPARATOR

HEALON

Intervention Type: DEVICE

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

Interventions

IXIUM TWIN

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

Intervention Type: DEVICE

HEALON

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

Intervention Type: DEVICE

Eligibility Criteria

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

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

Sponsors

LCA Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Patrice VINCENT

Role: CONTACT

pvincent@lca-pharma.com

02 37 33 39 30

Other Identifiers

2024-A01718-39

Identifier Type: OTHER

Identifier Source: secondary_id

2024-A01718-39

Identifier Type: -

Identifier Source: org_study_id