Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments and Lock-In: A Prospective Pilot Study
This observational pilot study will examine how a person's vision changes during the routine adjustment and finalization of a Light Adjustable Lens (LAL) after surgery. The study will focus on objective depth of focus, measured using iTrace wavefront analyzer, which describes how clearly a person can see at different distances. This is a non-invasive eye test that will be used alongside the standard lens adjustment process. This study will help researchers understand why some patients achieve unexpectedly good near or intermediate vision after LAL adjustments despite being targeted for emmetropia.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习地点
-
-
Ontario
-
Barrie、Ontario、加拿大、L4M 7G1
- 招聘中
- Lumea
-
接触：
- Jacqueline Sun
- 电话号码：705-300-0741
- 邮箱：Jsun@clarityeye.ca
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adults undergoing bilateral cataract surgery with LAL implantation as part of standard clinical care.
描述
Inclusion Criteria:
- Adults ≥18 years of age.
- Scheduled to undergo bilateral cataract extraction with LAL implantation as standard-of-care.
- Able to provide written informed consent.
- Able to comply with study visits and required assessments throughout the LAL adjustment and lock-in sequence.
Exclusion Criteria:
- Presence of ocular comorbidities in either eye that may affect visual outcomes or wavefront measurements, including but not limited to glaucoma, age-related macular degeneration, diabetic retinopathy, corneal disease, amblyopia, or prior refractive surgery.
- Intraoperative complications affecting IOL positioning, centration, or stability.
- Inability to obtain reliable iTrace measurements due to inadequate fixation or poor measurement quality.
- Participation in another interventional ophthalmic clinical study.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective Monocular Depth of Focus
大体时间：Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
Change in objective monocular depth of focus throughout the LAL UV adjustment and lock-in sequence, measured using the iTrace wavefront aberrometry system. Objective monocular depth of focus will be quantified using the VSOTF-based DOF profile and reported as the DOF range (D) at each timepoint. |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Uncorrected Distance Visual Acuity
大体时间：Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
UDVA monocular and binocular |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
|
Uncorrected Near Visual Acuity
大体时间：Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
UNVA monocular and binocular |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
|
Best Corrected Distance Visual Acuity
大体时间：Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
BCDVA monocular |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
|
Manifest Refraction
大体时间：Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
Manifest refraction (sphere, cylinder, axis) |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
iTrace-derived angle kappa
大体时间：Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
Angle Kappa from the iTrace will be taken at each step |
Baseline, prior to each UV adjustment, and prior to the first lock-in.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CEI-LAL-DOF-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.