Corneal Thickness Changes in Patient Undergoing Dry Eye Managment
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Corneal Thickness in microns
研究概览
简要总结
The purpose of this research is to the determine effect of dry eye and to compare the effect of artificial tears on central and peripheral corneal thickness.
详细描述
In this randomized controlled trial, 96 eyes of females with dry eye will be recruited through random sampling. Dry eye assessments will be done including TBUT, Schirmer test 1, and OSDI questionnaire. 96 eyes will be divided into 3 groups (32 eyes each) and will be provided intervention which is Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. , Dextran 0.1%Hypromellose 0.3%, and placebo(normal saline) through randomization by an unmasked investigator. Changes in central and peripheral corneal thickness will be evaluated by corneal topography. Patients will be evaluated at baseline, after 15 days, after 1 month, and re-evaluated after 1 month of cessation of treatment.
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
- Double (Participant, Investigator)
盲法说明
Both participant and investigator will be masked about the treatment options.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •● Females with ages ranging between 18-40 years and OSDI scores greater than 13, ametropia of up to 1DS of SE with astigmatism of less than 0.5DC, and Emmetropes.
排除标准
- •Refractive error of more than ±1 Ds of SE and astigmatism of greater than ±0.5DC.
- •Corneal surface disease other than dry eye disease.
- •Corneal ectasia.
- •Corneal or eyelid infections
- •Age < 18 and >40 years.
- •History of contact lens wears within the past three months.
- •Male will be excluded because sex has a large influence on the symptomatology of DED Males have significantly low symptom scores as compared to females.
- •Corneal surgeries.
- •History of ocular /systemic disease within the past 6 months.
- •The patients already receiving any kind of treatment for DED and other ocular diseases.
研究组 & 干预措施
Systane
Instill one drop three times a day for one month.
干预措施: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%, (Drug)
Tears Naturale 2
Instill one drop three times a day for one month.
干预措施: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%, (Drug)
Placebo
Instill one drop three times a day for one month.
干预措施: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%, (Drug)
结局指标
主要结局
Change in Corneal Thickness in microns
时间窗: one month
effect of dry eye treatment on the thickness of the cornea in microns measured by using corneal topography.
Change in Corneal Thickness in microns after treatment discontinuation.
时间窗: one month
after on month of treatment discontinuation access the change in corneal thickness in microns by using corneal topography.
次要结局
- Improvement in dry eye(one month)
研究者
Fatima Hussain
principal investigator
University of Faisalabad