Dry Eye Management With 3% Diquafosol Before and After Cataract Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Tear Break Up Time
研究概览
简要总结
The objective of this study is to evaluate the efficacy of Diquafosol 3% in the management of dry eyes before and after cataract surgery. Patients with pre-existing dry eyes and planned for cataract surgery will be started on Diquafosol eyedrops prior to surgery and treatment will be continued after cataract surgery. Eligible patients will undergo evaluation of dry eye at baseline and subsequently started on treatment with Diquafosol for the duration of 4 weeks before surgery. Further evaluations will be conducted on the day of surgery and at designated time points during and up to 12 weeks after surgery.
详细描述
Title: Dry Eye Management with 3% Diquafosol Before and After Cataract Surgery
Setting: LEC Eye Centre, Ipoh, Malaysia
Background: Dry eye disease and cataract are two conditions which have been known to increase in incidence with age. Dry eye disease can also be further exacerbated by cataract surgery. Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion and is a 'first in class' therapeutic option which has been shown repeatedly to be efficacious in dry eye management.
Objective: To evaluate the efficacy of Diquafosol for dry eye management in patients with pre-existing dry eye disease before and after cataract surgery
Design: Observational case series in a private ophthalmic health facility
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eyes with pre-existing dry eye and visually significant cataract planned for phacoemulsification
- •Patients aged18years or older and in good general health
- •Mild to moderate dry eye; non-visually significant ocular surface disease (NVS-OSD) defined as Corneal Fluorescein Staining (CFS) score of <3 on the Oxford scale
- •Tear break-up time (TBUT) <10 seconds
排除标准
- •Eyes with complications after cataract surgery which require a prolonged course of topical medication
- •Eyes with history of contact lens wear in the previous 3 months
- •Eyes with history of regular use of topical eye drops(except artificial tears) in the previous 6 months
- •Treatment history of dry eye beyond artificial tears
- •Eyes with significant ocular surface disease (defined as CFS score of ≥3 on the Oxford scale)
- •Eyes with lacrimal or eyelid disease or ocular surface infections
- •Any ocular surgery within the prior 6 months
- •Using medications that could affect the dry eye condition (eg, antihistamines, antidepressants, decongestants, anticholinergic drugs or hormone treatment)
- •Allergies to Diquafosol
结局指标
主要结局
Change in Tear Break Up Time
时间窗: 1 month preop, day of surgery, 1month and 3 months postoperatively
Measure of time taken for ocular tear film to disperse
Change in Conjunctival and corneal fluorescein staining score
时间窗: 1 month preop, day of surgery, 1month and 3 months postoperatively
Fluorescein scoring system based on NEI Grading
Change in Standard Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
时间窗: 1 month preop, day of surgery, 1month and 3 months postoperatively
A validated dry eye questionnaire designed to evaluate eye dryness prior to cataract surgery
次要结局
- Change in uncorrected and best corrected visual acuity(1 month preop, day of surgery, 1month and 3 months postoperatively)
研究者
Mun Wai Lee
Medical Director
LEC Eye Centre