Objective Assessment of Intraocular Lens Tilt and Decentration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt.
研究概览
简要总结
Prospective, multi-center, non-interventional, open label, randomized clinical study.
详细描述
The objective of this study is to evaluate the repeatability and reproducibility (R&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.
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
- •(ALL CRITERIA APPLY TO STUDY EYE)
- •Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms.
- •Appear capable and willing to adhere to the clinical protocol instructions.
- •Be 22 years of age or older at the time of screening.
- •Have undergone unilateral or bilateral implantation with a desired non-toric TECNIS IOL design (e.g., refractive or diffractive).
- •At least three months postoperative in the eligible eye.
排除标准
- •(ALL CRITERIA APPLY TO STUDY EYE)
- •Any medical or ocular history, in the opinion of the investigator, that may impact study procedures such as ocular trauma, pseudoexfoliation syndrome, retinal pigment degeneration, macular pathology, glaucoma, retinal disease, corneal disease, or corneal opacities.
- •Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
- •Have a history of corneal or intraocular surgery other than cataract surgery.
- •Using ocular or systemic medications known to interact with dilation drops.
- •Have a history of allergic reactions to dilation drops.
- •Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
- •Has an intraocular pressure of ≥ 21mm Hg before mydriasis.
- •Have a mydriatic pupil diameter of less than 6 mm.
- •Have participated in a clinical trial within 7 days prior to study enrollment.
- •An employee (e.g., Investigator, Coordinator, or Technician) or immediate family member (including partner, child, parent, grandparent, grandchild, or sibling) of an employee of the clinical site or study sponsor.
- •Currently pregnant or lactating.
研究组 & 干预措施
TECNIS diffractive non-toric IOL models
The primary objective of this study is to evaluate the repeatability and reproducibility (R&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS diffractive non-toric IOL models.
TECNIS refractive non-toric IOL models
The primary objective of this study is to evaluate the repeatability and reproducibility (R&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive non-toric IOL models.
干预措施: OCT Imaging Test (Diagnostic Test)
结局指标
主要结局
Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt.
时间窗: One study visit
The primary endpoints for this study will be: * Magnitude of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis. * Direction of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis. * Magnitude of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis. * Direction of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis.
次要结局
未报告次要终点