Corneal Thickness Changes in Patient Undergoing Dry Eye Managment
Overview
- Phase
- Not Applicable
- Intervention
- Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,
- Conditions
- Dry Eye Disease
- Sponsor
- University of Faisalabad
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Change in Corneal Thickness in microns
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Fatima Hussain
principal investigator
University of Faisalabad
Eligibility Criteria
Inclusion Criteria
- •● 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.
Exclusion Criteria
- •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.
Arms & Interventions
Systane
Instill one drop three times a day for one month.
Intervention: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,
Tears Naturale 2
Instill one drop three times a day for one month.
Intervention: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,
Placebo
Instill one drop three times a day for one month.
Intervention: Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,
Outcomes
Primary Outcomes
Change in Corneal Thickness in microns
Time Frame: 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.
Time Frame: one month
after on month of treatment discontinuation access the change in corneal thickness in microns by using corneal topography.
Secondary Outcomes
- Improvement in dry eye(one month)