An interventional study of IXIUM TWIN and HEALON in Cataract Surgery, sponsored by LCA Pharmaceutical. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by LCA Pharmaceutical · Not applicable, Interventional, and Supportive care
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.
LCA Pharmaceutical is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery
Device: IXIUM TWIN
HEALON as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery
Device: HEALON
Use of IXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgery
Use of HEALON as the Ophthalmic Viscosurgical Devices in the cataract surgery
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
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
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
Pachymetry
Measurement of corneal thickness
Time frame: 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).
Time frame: 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).
Time frame: Post-op
Patient satisfaction assessment regarding the procedure (Likert scale)
Patient satisfaction assessment regarding the procedure (Likert scale). Very satisfying - Satisfying - Acceptable - Insufficient
Time frame: 90 days
Assessment of adverse events
Assessment of adverse events at all visits
Time frame: 90 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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LCA Pharmaceutical