A Clinical Evaluation of a Phakic Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change in visual acuity
研究概览
简要总结
The objective of this study is to evaluate the clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens with Aspheric (EDOF) Optic as refractive elements to correct or reduce myopia or hyperopia with presbyopia with or without astigmatism.
详细描述
This prospective, open-labeled, evaluation of clinical performance of the investigational EDOF and Toric EDOF (TEDOF) ICL will be conducted at a single site in the Philippines.
Up to 45-50 subjects (90 eyes) who meet all eligibility criteria will be assigned to one of the following treatment arms, as determined by their preoperative refraction and the Investigator's medical judgement:
- EDOF Toric ICL in both eyes,
- EDOF Toric ICL in one eye and EDOF spherical ICL in fellow eye,
- EDOF spherical ICL in both eyes (up to 20 subjects/40 eyes).
Postoperatively, subjects will undergo ophthalmic examination at regular intervals per the study visit schedule up to 6 months after surgery.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Require a spherical lens power from -18.00 Diopters to +3.00 Diopters in both eyes or (in case of EDOF Toric) additional cylindrical lens power between +1.0 to +3.0 Diopters of Cylinder.
- •Stable refractive history (+/-0.50 Diopters) as determined by manifest spherical equivalent.
- •Requires +1.00 Diopters to +2.50 Diopters reading add in both eyes.
- •Minimum distance corrected near visual acuity of 20/40 or worse in both eyes.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •History of previous ocular surgery.
- •Progressive sight threatening disease.
- •Low/abnormal endothelial cell density.
- •Monocular.
- •Serious acute non-ophthalmic disease.
- •Pregnant or nursing women, or those who plan to become pregnant over the course of the study.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Change in visual acuity
时间窗: 1 month, 3 months and 6 months postoperatively
Change from baseline in uncorrected distance, intermediate and near visual acuity and distance corrected near visual acuity
Change in refractive cylinder
时间窗: 1 month, 3 months and 6 months postoperatively
Change from baseline in absolute magnitude of subjective refractive cylinder
Lens axis misalignment
时间窗: 1 month, 3 months and 6 months postoperatively
Proportion of lenses with axis misalignment compared to operative day
Rotational stability
时间窗: 1 day, 1, week, 1 month, 3 months and 6 months postoperatively
Rotational stability by assessment of IOL axis meridian compared to placement on day of surgery
Compromise in visual acuity
时间窗: 6 months postoperatively
Clinically significant compromise in visual acuity based on subject questionnaires
次要结局
未报告次要终点