IC-8 Apthera IOL New Enrollment Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 435
- 试验地点
- 19
- 主要终点
- Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment
研究概览
简要总结
The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.
详细描述
Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years of age or older, any race and any gender;
- •Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
- •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 visits;
- •Clear intraocular media in both eyes;
- •Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation;
- •Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL.
排除标准
- •Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye;
- •Irregular astigmatism in either eye;
- •History of retinal disease;
- •Active or recurrent anterior segment pathology;
- •Presence of ocular abnormalities;
- •Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment;
- •Previous corneal or intraocular surgery, except cataract surgery;
- •History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
- •Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study;
- •Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye;
- •Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study.
- •Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits
结局指标
主要结局
Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment
时间窗: 24 Months post IC-8 Apthera IOL Implantation
Rates of additional Nd:YAG laser treatments in the eye implanted with the IC-8 Apthera intraocular lens (IOL) beyond the initial Nd:YAG laser treatment will be assessed through 24 months post IC-8 Apthera IOL implantation
Rates of Secondary Surgical Interventions (SSIs)
时间窗: 24 Months post IC-8 Apthera IOL implantation
Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be assessed through 24 months post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ)
时间窗: 24 Months post IC-8 Apthera IOL implantation
Subjective responses to the Small Aperture Patient Questionnaire (SAPQ) that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
IOL related assessments
时间窗: 24 Months post IC-8 Apthera IOL implantation
The appearance of the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation
Rates of ocular adverse events
时间窗: 24 Months post IC-8 Apthera IOL implantation
Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Nd:YAG laser treatment outcome and/or complications
时间窗: 24 Months post IC-8 Apthera IOL Implantation
Nd:YAG laser treatment outcomes and/or complications in the eye implanted with the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation.
Rates of other serious adverse events
时间窗: 24 Months post IC-8 Apthera IOL implantation
Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire
时间窗: 24 Months post IC-8 Apthera IOL implantation
Subjective responses to the QoV Questionnaire that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
次要结局
未报告次要终点