Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-01-13 @ 7:40 AM
Study NCT ID:
NCT07279506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation of IXIUM TWIN Viscoelastic Ophthalmic Device For Cataract Surgery
Sponsor:
LCA Pharmaceutical
Organization:
Study Overview
Official Title:
Randomized Clinical Investigation Of The IXIUM TWIN Viscoelastic Ophthalmic Device (OVD) For Cataract Surgery With Intraocular Lens Implantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IXIUM_TWIN
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A01718-39 | OTHER | ANSM | View |