Dry eye syndrome, meibomian gland dysfunction Eye Diseases Other disorders of lacrimal gland
Conditions
Interventions
Current interventions as of 28/01/2021:
Eligible patients are randomized using the random number method into two treatment groups. The first group will use 3% diquafosol sodium ophthal
Sponsors
Pusan National University Yangsan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 28/01/2021: In order to be eligible for participation in this study, the subject had to: 1. Be male or female, aged 19 years or older 2. Have a tear breakup time (TBUT) of 10 seconds or more 3. Have a Schirmer’s I test result of 10 mm or more 4. Have not used diquafosol-based eye drops, artificial tear drops, steroid eye drops, or antibiotic eye drops within 3 months before participation 5. Show normal blinking during a slit lamp exam 6. Voluntarily agree to participate in this study Previous inclusion criteria: Adult cataract patients with normal lid position and closure and not suffering from any ocular diseases
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/01/2021: The subject is excluded from the study if the subject either: 1. Has Sjögren's syndrome 2. Has severe blepharitis 3. Had ocular surgery or laser eye surgery 4. Has severe ocular inflammation/infection 5. Is using eye drop treatment for dry eyes, such as glaucoma or allergies 6. Shows sensitivity to the study drugs 7. Is considered to be ineligible for participation owing to reasons other than the aforementioned exclusion criteria based on the judgment of the principal researcher Previous exclusion criteria: 1. Patients who had used topical anti-inflammatory, antibiotic, or other medication during the previous 90 days before surgery 2. Eyes with a history of trauma, ocular surgery, laser or systemic treatment known to affect tear secretion, autoimmune disease, current use of contact lenses, and/or history of slit-lamp evidence of eye surface disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 28/01/2021: Measured at baseline (1 week before cataract surgery) and 3, 7, 15 weeks after cataract surgery: 1. Ocular surface status parameters: 1.1. Lipid layer thickness (LLT) measured using an interferometer 1.2. Schirmer’s type I test using COLOR BAR by Eagle Vision Inc. 1.3. Tear breakup time (TBUT) measured by an ophthalmologist 2. Patients’ symptoms measured using Ocular Surface Disease Index (OSDI) questionnaire Previous primary outcome measure: Measured at baseline and 4 months: 1. Ocular surface status parameters: 1.1. Lipid layer thickness (LLT) measured using an interferometer 1.2. Schirmer’s type I test using COLOR BAR by Eagle Vision Inc. 1.3. Tear breakup time (TBUT) measured by an ophthalmologist 2. Patients’ symptoms measured using Ocular Surface Disease Index (OSDI) questionnaire 3. Meibomian gland dysfunction assessed using Meiboscores with the LipiView® interferometer | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Korea, South
Outcome results
None listed