Cataract SurgeryIXIUM_TWINNCT07279506
Clinical Investigation of IXIUM TWIN Viscoelastic Ophthalmic Device For Cataract Surgery
A study testing IXIUM TWIN and HEALON in people with Cataract Surgery, run by LCA Pharmaceutical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- IXIUM TWIN and HEALON
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- IXIUM TWIN, HEALON
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXIUM TWINDevice
Use of IXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgery
HEALONDevice
Use of HEALON as the Ophthalmic Viscosurgical Devices in the cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| IXIUM TWIN | Experimental | IXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery Receives: Device: IXIUM TWIN |
| HEALON | Active comparator | HEALON as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery Receives: Device: HEALON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 90 days
Secondary outcomes (7)
Proportion of patients with intraocular pressure (IOP) ≥30 mmHg
Proportion of patients with intraocular pressure (IOP) ≥30 mmHg at each visit.
Measured: 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+)
Measured: 90 days
Pachymetry
Measurement of corneal thickness
Measured: 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).
Measured: 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).
Measured: Post-op
Patient satisfaction assessment regarding the procedure (Likert scale)
Patient satisfaction assessment regarding the procedure (Likert scale). Very satisfying - Satisfying - Acceptable - Insufficient
Measured: 90 days
Assessment of adverse events
Assessment of adverse events at all visits
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LCA Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279506
- Sponsor's protocol ID
- 2024-A01718-39
- Other IDs
- 2024-A01718-39
- Acronym
- IXIUM_TWIN
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Investigation Of The IXIUM TWIN Viscoelastic Ophthalmic Device (OVD) For Cataract Surgery With Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT07279506
- Acronym / sponsor ID
- IXIUM_TWIN / 2024-A01718-39
- Conditions
- Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- LCA PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IXIUM TWIN | Experimental | Device: IXIUM TWINIXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery |
| HEALON | Active comparator | Device: HEALONHEALON as the Ophthalmic Viscosurgical Devices in the cataract surgeryfor the cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IXIUM TWINUse of IXIUM TWIN as the Ophthalmic Viscosurgical Devices in the cataract surgery | Device | IXIUM TWIN |
| HEALONUse of HEALON as the Ophthalmic Viscosurgical Devices in the cataract surgery | Device | HEALON |
Primary outcome
Percentage of Endothelial Cell Loss between pre- and post-operative periods
Time frame: 90 days
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%.
7 secondary outcomes
Proportion of patients with intraocular pressure (IOP) ≥30 mmHg
Time frame: 90 days
Slit-lamp biomicroscopy
Time frame: 90 days
Pachymetry
Time frame: 90 days
Best-corrected visual acuity (BCVA) for distance and near vision
Time frame: 90 days
Assessment of the viscoelastic device (DM) behavior
Time frame: Post-op
Patient satisfaction assessment regarding the procedure (Likert scale)
Time frame: 90 days
Assessment of adverse events
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
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Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing IXIUM TWIN and HEALON in people with Cataract Surgery, run by LCA Pharmaceutical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrice VINCENT (02 37 33 39 30, pvincent@lca-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Endothelial Cell Loss between pre- and post-operative periods (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.