NCT02378636撤回不适用
Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rotational Stability
研究概览
简要总结
This will be a prospective, open-label, 125 subject (maximum), two-year multicentre investigation to assess the safety, effectiveness and rotational stability of the modified 600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥21 years of age.
- •Cataract for which phacoemulsification extraction and posterior IOL implantation has been planned for the operative eye.
- •Best corrected distance visual acuity (BCDVA) projected to be better than 20/30 (+0.18 logMAR) in the operative eye after cataract removal and IOL implantation.
- •Calculated IOL power requirement within the range +8.0 to +34.0D
- •If present, subject must have corneal astigmatism of <1.50 D in the operative eye.
- •Expected dilated pupil size ≥ 5.0 mm in diameter to visualise the axis markings
- •Subject must provide written informed consent.
- •Subject must be able to return for scheduled follow-up examinations for 24 months after surgery.
排除标准
- •History of ocular trauma or prior ocular surgery in the operative eye.
- •Microphthalmia
- •Corneal decompensation or endothelial insufficiency
- •Pseudo exfoliation
- •Pars planitis
- •Subjects with diagnosed degenerative visual disorders in the operative eye (e.g.,macular degeneration or other retinal disorders) that are predicted to cause future visual acuity losses to a level of 20/30 (+0.18 logMAR) or worse.
- •Inability to achieve secure placement in the designated location e.g. absence of a secure peripheral anterior capsule, zonule laxity or dehiscence; posterior synechiae to the capsular bag
- •Active ocular disease in the operative eye, e.g., clinically significant dystrophy, chronic severe uveitis, proliferative diabetic retinopathy, or chronic glaucoma.
- •Concurrent participation in another drug or device investigation.
- •Patients who are expected to require retinal laser treatment.
- •Females who are pregnant, nursing or plan to become pregnant during the study.
结局指标
主要结局
Rotational Stability
时间窗: 180 Day
IOL rotation will be measured through retro-illumination photography between 0-3 hours post-operatively and this will be compared with images from Day 120-180 to determine degree of IOL rotation in accordance with ISO-11979-7:2014 requirements
Best Corrected Distance Visual Acuity (BCDVA)
时间窗: 180 Day
Best Corrected Distance Visual Acuity
次要结局
未报告次要终点
研究者
研究点 (2)
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