LacriFill Canalicular Occlusion for Dry Eye After LASIK
Impact of LacriFill Lacrimal Occlusion on Post-LASIK Dry Eye Symptoms, Ocular Surface Recovery, and Patient-Reported Visual Quality
This study is a single-site, prospective, randomized (2:1) controlled study of subjects aged 18-39 who are candidates for bilateral LASIK and have dry eye symptoms (OSDI ≥13). The LacriFill group (n=50) receives bilateral lower canalicular LacriFill placement within 7 days prior to surgery plus standard postoperative care; the control group (n=25) receives standard postoperative care only. The primary outcome is the change in Ocular Surface Disease Index (OSDI) score from baseline to 3 months after bilateral LASIK.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Melissa Hamann Wright, Study Staff
- 电话号码：2389 713-580-2500
- 邮箱：Melissa.Wright@manneye.com
学习地点
-
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Texas
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Houston、Texas、美国、77004
- Mann Eye Institute
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接触：
- Melissa Hamann Wright
- 电话号码：2389 713-580-2500
- 邮箱：Melissa.Wright@manneye.com
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首席研究员：
- Phillip Brunson, OD
-
-
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
描述
Inclusion Criteria:
Age 18-39 years. Bilateral LASIK candidate. OSDI ≥13. BCDVA 20/20 or better. Discontinue soft contact lenses within 5 days of surgery and RGP lenses 4 weeks prior.
Able to complete study visits.
Exclusion Criteria:
Previous ocular surgery. Keratoconus or ectasia. Autoimmune disease. Pregnancy. Uncontrolled diabetes. Significant ocular surface disease unrelated to LASIK. Active ocular infection or inflammation.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：LacriFill Group
Standard postoperative LASIK care plus bilateral lower canalicular LacriFill placement within 7 days prior to surgery (n=50). |
LacriFill, a crosslinked hyaluronic acid-based bioresorbable gel, instilled for bilateral lower canalicular occlusion within 7 days prior to LASIK surgery. |
|
无干预：Control Group
Standard postoperative LASIK care only; no punctal plugs, LacriFill, or other canalicular occlusion before completion of the primary 3-month endpoint unless medically necessary as rescue therapy (n=25). |
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 |
|---|---|---|
|
Change from baseline in Ocular Surface Disease Index (OSDI) score
大体时间：12 weeks
|
The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function. |
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Ocular Surface Disease Index (OSDI) score
大体时间：12 weeks
|
The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function. |
12 weeks
|
|
Proportion of subjects achieving ≥10-point improvement in OSDI score
大体时间：12 weeks
|
Proportion of subjects achieving an improvement of 10 points or more in OSDI score from baseline following bilateral LASIK. |
12 weeks
|
|
Proportion of subjects achieving OSDI score <13
大体时间：12 weeks
|
Proportion of subjects with an OSDI score below 13 (normal range) at the 12-week postoperative visit. |
12 weeks
|
|
Change from baseline in tear break-up time (TBUT)
大体时间：12 weeks
|
12 weeks
|
|
|
Change from baseline in corneal fluorescein staining (National Eye Institute Corneal Staining Scale)
大体时间：12 weeks
|
12 weeks
|
|
|
Uncorrected distance visual acuity (UDVA)
大体时间：12 weeks
|
12 weeks
|
|
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Corrected distance visual acuity (CDVA)
大体时间：12 weeks
|
12 weeks
|
|
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Manifest refraction
大体时间：12 weeks
|
12 weeks
|
|
|
Artificial tear usage and time to discontinuation of routine artificial tears
大体时间：12 weeks
|
Artificial tear usage, time to discontinuation of routine artificial tears, and requirement for rescue dry eye therapy through the 12-week postoperative visit. |
12 weeks
|
|
Requirement for rescue dry eye therapy
大体时间：12 weeks
|
Incidence and documentation (indication, timing, treatment administered) of rescue dry eye therapy through the 12-week postoperative visit. |
12 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PROWL-SS Questionnaire
大体时间：12 weeks
|
PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). |
12 weeks
|
|
Change from baseline in iTrace Corneal Performance Index (CPI)
大体时间：12 weeks
|
Objective optical quality measure assessed at baseline and12-week postoperative visit. |
12 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
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
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