Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Monocular UCNVA
研究概览
简要总结
The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal.
详细描述
This will be a prospective, non-randomized, single-arm, single-visit, single-center, clinical study in up to 40 patients previously contralaterally implanted with the IC-8 IOL at one clinical site in Singapore.
The purpose of this study is to to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. The co-primary study endpoints are monocular uncorrected distance, intermediate, near visual acuities.
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
- 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);
- •Having complex corneas prior to cataract surgery;
- •Previous cataract surgery and IC-8 IOL implantation in the eye (implanted for 3 months or longer prior to study participation).
排除标准
- •Baseline visual acuity worse than 20/25 BCDVA in either eye;
- •Presence of ocular abnormalities or conditions other than corneal irregularities that could confound the study outcome(s), such as:
- •Strabismus or amblyopia
- •Retinal or macular abnormalities
- •Recurrent and/or persistent ocular inflammation
- •Known pathology that may affect visual acuity to a level worse than 20/25 BCDVA
- •Previous intraocular surgery, except cataract surgery, pterygium surgery, or corneal procedures (other than corneal-cross linking);
- •Previous corneal cross-linking procedure with any corneal haze;
- •Conditions requiring planned ocular surgical intervention, except Nd:YAG capsulotomy;
- •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;
- •Patient is pregnant or nursing.
结局指标
主要结局
Monocular UCNVA
时间窗: 3 Months
not worse than 0.3 logMAR
Monocular UCDVA
时间窗: 3 Months
0.3 logMAR or better
Monocular UCIVA
时间窗: 3 Months
0.3 logMAR or better
次要结局
未报告次要终点