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Clinical Investigation of IXIUM TWIN Viscoelastic Ophthalmic Device For Cataract Surgery

NCT07279506 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

DEVICE

IXIUM TWIN

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

DEVICE

HEALON

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

Sponsors & Collaborators

  • LCA Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-09-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279506 on ClinicalTrials.gov