Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- OSDI Dry Eye Questionnaire
研究概览
简要总结
Regular use of Systane COMPLETE in dry eye subjects before cataract surgery may optimize the ocular surface.
详细描述
STUDY OBJECTIVE：To evaluate the impact of predicted residual astigmatism in mixed dry eye patients regularly using Systane COMPLETE before cataract surgery.
Hypothesis：Regular use of Systane COMPLETE in mixed dry eye subjects before cataract surgery may lead to more accurate astigmatism predictions.
Objectives：To evaluate the Impact of predicted residual astigmatism in mixed dry eye patients regularly using Systane COMPLETE before cataract surgery.
Inclusion Criteria The subjects aged 20-85 years, with normal cognitive function and capable of answering related questionnaires who require phacoemulsification and intraocular lens implantation under topical anaesthesia, are the eligible candidates.
Exclusion Criteria Unable to answer the questions in the dry eye survey. Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects aged 20-85 years, with normal cognitive function and capable of answering related questionnaires who require phacoemulsification and intraocular lens implantation under topical anaesthesia, are the eligible candidates.
排除标准
- •Unable to answer the questions in the dry eye survey.
- •Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
- •Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect
- •Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.
- •Using dry eye medication at screening stage
研究组 & 干预措施
Experimental group
Prospective, single-arm study
干预措施: Systane COMPLETE (Drug)
结局指标
主要结局
OSDI Dry Eye Questionnaire
时间窗: 1-2 months
The Ocular Surface Disease Index (OSDI) questionnaire is a tool designed to evaluate dry eye symptoms, focusing on three aspects: self-reported eye discomfort, visual function impairment, and environmental triggers. The questionnaire contains 12 items, each rated on a scale from 0 to 4, with a total score ranging from 0 to 100. Higher scores indicate more severe dry eye symptoms. The OSDI questionnaire has high reliability and validity, aiding healthcare professionals in quickly assessing the severity of dry eye, making it suitable for clinical diagnosis and treatment evaluation.
Preoperative Assessments for Cataract Surgery at NTUH: Vision Measurement
时间窗: 1-2 months
Vision measurement is a core component of the preoperative baseline assessment, providing information on the patient's uncorrected and corrected visual acuity. This data helps determine the necessity of surgery and establish postoperative vision expectations.
Preoperative Assessments for Cataract Surgery at NTUH: Biometry
时间窗: 1-2 months
Biometry is an essential part of the preoperative evaluation, providing critical measurements that guide the selection of the appropriate intraocular lens. This assessment ensures precise surgical planning and contributes to achieving optimal visual outcomes postoperatively.
Preoperative Assessments for Cataract Surgery at NTUH: Pentacam(Corneal topography maps)
时间窗: 1-2 months
Pentacam is a vital component of the preoperative assessment, offering detailed corneal mapping that aids in evaluating corneal structure and detecting any abnormalities. This information supports surgical planning and enhances the accuracy of intraocular lens selection, contributing to improved postoperative visual outcomes.
K5 (Non-Invasive Tear Break-Up Time (NITBUT))
时间窗: 1-2 months
K5 (Non-Invasive Tear Break-Up Time (NITBUT)) is used to evaluate tear film stability, a key diagnostic indicator for dry eye. It is crucial for enhancing postoperative visual quality.
次要结局
未报告次要终点