Randomized Clinical Investigation Of The IXIUM TWIN Viscoelastic Ophthalmic Device (OVD) For Cataract Surgery With Intraocular Lens Implantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Percentage of Endothelial Cell Loss between pre- and post-operative periods
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of Endothelial Cell Loss between pre- and post-operative periods
时间窗: 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%.
次要结局
- Slit-lamp biomicroscopy(90 days)
- Pachymetry(90 days)
- Best-corrected visual acuity (BCVA) for distance and near vision(90 days)
- Assessment of the viscoelastic device (DM) behavior(Post-op)
- Patient satisfaction assessment regarding the procedure (Likert scale)(90 days)
- Assessment of adverse events(90 days)
- Proportion of patients with intraocular pressure (IOP) ≥30 mmHg(90 days)
- Slit-lamp biomicroscopy(90 days)
- Pachymetry(90 days)
- Best-corrected visual acuity (BCVA) for distance and near vision(90 days)
- Assessment of the viscoelastic device (DM) behavior(Post-op)
- Patient satisfaction assessment regarding the procedure (Likert scale)(90 days)
- Assessment of adverse events(90 days)