Meibomian Gland Dysfunction.
Conditions
Interventions
Intervention 1: Intervention group: one affected eye of each patient will be enrolled in the study as the treatment eye. In addition to standard care, including eyelid hygiene and warm compresses, top
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Being at the age of 40–65 years Individuals exhibiting symptoms of dry eye and a tear break-up time (TBUT) of less than 10 seconds, attributable exclusively to Meibomian gland dysfunction
Exclusion criteria
Exclusion criteria: Oral statin administration Use of doxycycline or other medications affecting MGD, such as azithromycin Unwillingness to participate in the study Hematologic or coagulation disorders; use of anticoagulant medications such as warfarin or Coumadin History of peptic ulcer disease Presence of concurrent ocular malignancies History of ocular surgery within the past three months History of ocular trauma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular surface disease index (OSDI) score. Timepoint: Measurement of the OSDI questionnaire score at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo. Method of measurement: Ocular surface disease index is a questionnaire that assesses ocular symptoms, visual function, and environmental aggravating factors related to dry eye disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tear break up time (TBUT). Timepoint: Measurement of TBUT at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo. Method of measurement: The time interval between fluorescein staining of the conjunctival cul-de-sac and the appearance of the first dry spot on the corneal surface.;The number of stained spots on the cornea and conjunctiva observed during fluorescein staining. Timepoint: Measurement of Fluorescein staining at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo. Method of measurement: The number of stained spots on the cornea and conjunctiva, evaluated according to the Oxford grading scale.;The length in millimeters of a standard filter paper strip wetted by the patient’s tears after 5 minutes (Schirmer test). Timepoint: Measurement of Schirmer test at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo. Method of measurement: Schirmer test: The length, in millimeters, of a standard Schirmer strip wetted by the patient's tear fluid after 5 minutes.;Dry eye questionnaire (DEQ5) score. Timepoint: Measurement of DEQ5 score at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo. Method of measurement: A self-administered questionnaire used to assess the presence and severity of dry eye symptoms.;Meibomian gland expressibility. Timepoint: Measurement of Meibomian gland expressibility at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo. Method of measurement: Evaluation of the meibomian glands in the lower eyelid is performed by applying approximately 1.20 grams per square millimeter of pressure to the nasal, central, and temporal regions. Lipid secretion from the gland orifices is assessed and graded on a scale from 0 to 4:Grade 0: secretion from more than 75% of the glands; Grade 1: secretion from 50–75% | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSalar Bahrami
Shahid Beheshti University of Medical Sciences
Outcome results
None listed