Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Monocular uncorrected intermediate visual acuity (UCIVA)
研究概览
简要总结
The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.
详细描述
This is a prospective, multi-center, open-label, non-randomized, single-arm clinical investigation with planned postoperative follow-up of 4-6 months. The monocular and binocular performance of the subjects will be evaluated.
The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.
The co-primary effectiveness endpoints are monocular uncorrected distance, intermediate, and near visual acuities at 4-6 Months postoperative. The primary safety endpoint is best-corrected distance visual acuity at 4-6 Months postoperative. The secondary safety endpoint is photopic and mesopic contrast sensitivity at 4-6 Months postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum 22 years of age;
- •Able to comprehend and have signed a statement of informed consent;
- •Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s);
- •Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation;
- •Planned cataract removal or planned clear lens exchange in both eyes
- •Potential for postoperative best-corrected distance visual acuity (BCDVA) of 20/32 or better after crystalline lens removal;
- •Having complex corneas with irregular astigmatism
- •Having clear central cornea
- •Having best-corrected distance visual acuity (BCDVA) or 20/40 or worse in either eye with or without a glare source (patients with bilateral cataract).
排除标准
- •Requiring an IC-8 IOL outside the available spherical power range;
- •Pharmacologically dilated pupil size less than 6 mm in either eye;
- •Preoperative corneal astigmatism >1.50 diopters in the eye to be implanted with the IC-8 IOL;
- •Active or recurrent anterior segment pathology;
- •Presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol;
- •Congenital bilateral cataracts;
- •Previous ocular surgery as specified by the protocol;
- •Conditions requiring planned ocular surgical intervention;
- •Severe dry eye or other conditions (such as hormonal fluctuations) that could lead to unstable refraction and/or visual acuity measurements or eye discomfort even with ocular lubricants or dry eye medication;
- •Use of systemic or ocular medications as specified by the protocol;
- •Concurrent participation or participation in any clinical investigation up to 30 days prior to preoperative visit;
- •Patient is pregnant or nursing.
结局指标
主要结局
Monocular uncorrected intermediate visual acuity (UCIVA)
时间窗: 4-6 Months
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular uncorrected distance visual acuity (UCDVA)
时间窗: 4-6 Months
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular uncorrected near visual acuity (UCNVA)
时间窗: 4-6 Months
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye
时间窗: 4-6 Months
Mean best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye at 4-6 Months is not statistically worse than 0.2 logMAR
次要结局
- Monocular and Binocular Contrast Sensitivity(4-6 Months)