dry eyes. Dry eye syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with moderate or severe dry eye disease who have been diagnosed by a physician according to the criteria for Dry Eye Disease. - Age between 18 and 70years. Willingness to participate in the research and obtain informed consent.
Exclusion criteria
Exclusion criteria: Having serious eye diseases such as glaucoma, cataracts or corneal problems. Having systemic diseases that may affect the results of treatment (such as uncontrolled diabetes). Taking certain medications that have a direct effect on dry eyes (such as steroid medications). Discontinuing treatment or not cooperating during the study. In case of serious complications that require immediate medical attention, the patient will be withdrawn from the study and will receive specialized treatment. Patients with active or uncontrolled autoimmune diseases will be excluded from the study. “Controlled” disease means that the patient’s clinical condition has been stable for at least 6 months prior to study entry and there has been no change in the dose or type of their systemic medications during this period. Also, patients who are taking high doses of systemic corticosteroids or new biologics will be excluded from the study to avoid the severe effects of these drugs on dry eye outcomes. Patients with severe dry eye, based on clinical criteria and standardized questionnaires (such as high OSDI Score), will be excluded from the study. The study will focus on patients with mild to moderate dry eye to avoid the disproportionate effects and complications of severe dry eye, which may require more complex therapeutic interventions. Patients with a diagnosis of Sjögren’s Syndrome, Graft-versus-Host Disease, and Stevens-Johnson Syndrome will be excluded from the study due to the complex nature and widespread effects of these diseases on the ocular surface.” “If any participant does not demonstrate an adequate response to their intervention or experiences worsening clinical symptoms and dry eye indices (based on pre-specified criteria, such as a significant increase in OSDI or a decrease in TBUT/Schirmer) during the study period, they will be removed from the study and referred to a physician for further evaluation and appropriate treatment. This is done to protect the patient’s health and to prevent misleading results in the final analysis.”
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dry eye severity based on Schirmer test_Dry eye severity based on tear film break-up time (TBUT) test_Ocular Surface Disease Index (OSDI). Timepoint: Beginning of the study and end of the study. Method of measurement: Dry eye severity based on Schirmer test_Dry eye severity based on tear film break-up time (TBUT) test_Ocular Surface Disease Index (OSDI). | — |
Countries
Iran (Islamic Republic of)
Contacts
Shiraz University of Medical Sciences