Severe dry eye. Dry eye syndrome of unspecified lacrimal gland
Conditions
Interventions
Intervention Group: A group of 30 individuals diagnosed with dry eye disease which will referred to the Vision Health Clinic will enrolled in the study. The medication consists of eye drops containin
Sponsors
Vision health research center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: People with severe dry eye based on symptoms in at least one eye: dryness, burning sensation, foreign body sensation, discomfort in the ocular surface or visual fatigue Failure to respond to routine treatments Tear secretion test (Schirmer test) both eyes = 10 mm / 5 minutes.
Exclusion criteria
Exclusion criteria: Those who are allergic to any of the drug components in this study. Pregnant or lactating women Patients with active fungal, bacterial or viral keratitis or conjunctivitis Suffering from serious heart, lung, liver, or kidney diseases; Patients with Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with increasing of Tear Film Break-up Time. Timepoint: Before intervention, one week, 4 weeks and 12 weeks after intervention. Method of measurement: The time required for dry spots to appear on the surface of the eye after blinking is in seconds. A positive change from baseline indicates improvement in each eye.;Ocular Surface Staining. Timepoint: Before intervention, one week, 4 weeks and 12 weeks after intervention. Method of measurement: An area of the cornea that is stained with fluorescein dye and it will be assessed using a slate lamp microscope. Ocular surface damage will be measured by slit lamp examination after staining with non-toxic sodium fluorescein. Corneal and conjunctival staining will be graded based on the National Eye Institute (NEI) imaging scale. The lower the score has the less dry eye symptoms the patient. A negative change from baseline indicates improvement in each eye.;The volume of tear. Timepoint: Before intervention, one week, 4 weeks and 12 weeks after intervention. Method of measurement: A paper strip is placed on the eye under the lower eyelid for a certain period of time. The length of the tear-soaked strip will be measured in millimeters. A positive change from baseline indicates improvement in each eye. | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity. Timepoint: Before intervention, 1week, 1 month and 3 months after intervention. Method of measurement: Measurement of vision based on Snellen chart.;Best corrected visual acuity. Timepoint: Before intervention, 1week, 1 month and 3 months after intervention. Method of measurement: Measurement of vision based on Snellen chart. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Aghamollaei
Vision health research center
Outcome results
None listed