Vault Evaluation After Implantation of an Implantable Collamer Lens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation
研究概览
简要总结
The purpose of this study is to evaluate the lens vault after implantation of an implantable collamer lens (ICL). The ICL is designed to be implanted in front of the eye, without removing the natural lens. Because of this, it is also known as a phakic IOL. The ICL has already been approved by the U.S. Food and Drug Administration (FDA) to treat mid to high degrees of refractive errors such nearsightedness (also called myopia) with or without astigmatism. Once the artificial lens is implanted, a space between the ICL and the crystalline lens is created, which is called vault.
详细描述
The ICL will be implanted in both eyes of study subjects. Diagnostic instrumentation will be used to measure the vault between the ICL and the crystalline lens.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: Males and Females.
- •Age: 21 to 45 years of age
- •Willing and able to provide written informed consent for participation in the study
- •Willing and able to comply with scheduled visits and other study procedures.
- •Scheduled to undergo ICL implantation in both eyes within 1 to 30 days between surgeries.
- •Subjects who require an ICL power in the range of -3.00 to -15.00 D.
排除标准
- •Patients who do not qualify for an ICL according to the Direction For Use (DFU)
- •Unstable or worsening myopia
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Irregular astigmatism.
- •History of retinal detachment.
- •Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- •Pigment dispersion
- •Previous intraocular surgery.
- •Previous refractive surgery.
- •Previous keratoplasty
- •Pupil abnormalities
- •Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- •Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
结局指标
主要结局
Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation
时间窗: 1-month
Difference between the predicted vault at the preoperative visit and the actual vault measured at the 1-month visit
次要结局
未报告次要终点