Optimizing the Ocular Surface With Systane COMPLETE Pre- and Post-operatively in Patients With Dry Eye Planning for Cataract Surgery: An Extension Study of 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
- 140
- 试验地点
- 2
- 主要终点
- The change of the keratometry data before and after using Systane COMPLETE
研究概览
简要总结
Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism, as well as the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).
详细描述
STUDY OBJECTIVE： Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism.
Compare the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).
Background Cataract surgery is one of the most common and successful ophthalmic surgeries worldwide. However, cataract surgery can induce or exacerbate the severity of dry eye, leading to increased postoperative discomfort for patients. Additionally, undiagnosed preoperative dry eye can affect the accuracy of corneal astigmatism measurements, potentially impacting the astigmatic correction power of toric intraocular lenses used during surgery.
While general moisturizing artificial tears have been shown to significantly reduce postoperative ocular discomfort and tear film instability, it is notable that up to 50% of patients undergoing refractive or cataract surgery exhibit abnormalities in the tear film lipid layer, meeting the diagnostic criteria for meibomian gland dysfunction (MGD).
Given this, the application of lipid-containing nano-emulsion artificial tears before and after cataract surgery presents an unexplored opportunity to address two critical issues: reducing errors in corneal astigmatism measurements and alleviating dry eye symptoms induced by cataract surgery. This remains a topic worthy of investigation, as no existing studies have thoroughly examined these aspects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •(Experimental group ): Cataract patients who participated in the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval Number: 202311109MIPD) and did not withdraw from the trial midway.
排除标准
- •(Experimental group ): Patients unwilling to participate in this trial after surgery.
- •Inclusion Criteria(Control group):
- •Cataract patients aged between 20 and 85 years.
- •Patients with normal cognitive function who are able to complete the dry eye questionnaire (with - responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens implantation under topical anesthesia.
- •Exclusion Criteria (Control group):
- •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
Systane COMPLETE
The experimental group will receive Systane COMPLETE for one month before undergoing the cataract surgery and receive for one month since one week after the surgery.
干预措施: Systane Complete (Drug)
Control group
The control group will enrolled people who meet the same age and same dry eye syndrome criteria as the experimental group. The control group will not received any intervention.
结局指标
主要结局
The change of the keratometry data before and after using Systane COMPLETE
时间窗: 1-2 months
The change of the keratometry data is assessed for investigating ocular surface stability after using Systane COMPLETE. The keratometry data is measured using auto-refractor.
次要结局
- The change of the refractive power before and after using Systane COMPLETE(1-2 months)
- The change of the biometry parameter before and after using Systane COMPLETE(1-2 months)
- The change of corneal topology map before and after using Systane COMPLETE(1-2 months)
- The change of Ocular Surface Disease Index (OSDI) before and after using Systane COMPLETE(1-2 months)
- The change of Non-Invasive Tear Break-Up Time (NITBUT) before and after using Systane COMPLETE(1-2 months)