The Efficacy of the Systane iLux System on Preoperative Cataract Patients on Dry Eye Disease Due to Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changed in Lipid Layer Thickness (LLT) measurement from baseline visit
研究概览
简要总结
This prospective study will investigate the effect of pre-operative Systane iLux system administration in treated cataract induced dry eye disease.
详细描述
Eligible patients to be recruited will have scheduled upcoming senile cataract surgery. Enrolled patients in the active arm (n=25) will receive pre-operative Systane iLux treatment two weeks prior to surgery at the baseline visit. Patients in the control arm will receive no Systane iLux treatment at the baseline visit two weeks prior to cataract surgery. Patients will be assessed on baseline metrics for dry eye disease stemming and meibomian gland dysfunction (MGD) at the baseline visit two weeks prior to cataract surgery. These metrics include tear break up time (TBUT), standard patient evaluation of eye dryness questionnaire (SPEED), ocular surface and surface disease index (OSDI) surveys, and lipid layer thickness (LLT). At the follow up visit four weeks after cataract surgery, these same metrics will be assessed again for any significant changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than 18 at the time of informed consent
- •Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions
- •Upcoming scheduled senile cataract surgery
排除标准
- •Eyelid abnormalities
- •Patients with active ocular infection, active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
- •Ocular surgery within the last 6 months
- •Occlusion therapy with lacrimal or punctum plugs within the last 3 months
- •Patients with an ocular surface abnormality that may compromise corneal integrity
- •Patients with ocular injury or trauma, chemical burns, or limbal stem cell deficiency (within prior 3 months)
- •Patients with cicatricial lid margin disease
- •patients with lid surface abnormalities that affect lid function in either eye; patients with aphakia
- •Patients with permanent makeup or tattoos on their eyelids.
- •Previous application/administration of Systane iLux or LipiFlow treatment
研究组 & 干预措施
Control: No Systane iLux Treatment
No Systane iLux treatment at baseline visit two weeks prior to cataract surgery.
Systane iLux Treatment
Systane iLux administration at baseline visit two weeks prior to cataract surgery.
干预措施: Systane iLux Treatment (Device)
结局指标
主要结局
Changed in Lipid Layer Thickness (LLT) measurement from baseline visit
时间窗: 6 weeks
To assess improvement in tear film lipid layer by imaging through LipiView II. Thin lipid layer thickness (\<60 nm) indicates a tear film instability and therefore an increased evaporation rate, high osmolarity, and dry eye symptoms. In contrast, a thicker lipid layer thickness (\<120 nm) indicates a more stable tear film stability
Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up
时间窗: Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery
Lipid layer thickness (LLT) was measured using LipiView II and reported in nanometers (nm). Higher values indicate a thicker lipid layer and improved tear film stability. Assessments were performed at both time points in the eye undergoing cataract surgery (one eye per participant). Change was calculated as the value at 4 weeks post-operatively minus the value at baseline. Negative values indicate a decrease from baseline.
次要结局
- Change in ocular surface and disease index (OSDI) score questionnaire from baseline visit(6 weeks)
- Change in standard patient evaluation of eye dryness questionnaire (SPEED) questionnaire from baseline visit(6 weeks)
- Mean change from baseline of Fluorescein Tear Break-Up Time (TBUT) from baseline visit(6 weeks)
- Change from baseline in Meibomian Gland Score (MGS)(6 weeks)
- Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up(Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery)
- Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up(Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery)
- Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up(Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery)
研究者
Keith Wroblewksi
Principal Investigator
George Washington University