None listed
Conditions
Interventions
Medical Device : The clinical trial will be conducted at Daegu Catholic University Hospital, following the principles of informed consent, screening, and the treatment process. The trial consists of a
Sponsors
Daegu Catholic University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with an Ocular Surface Disease Index (OSDI) score of 13 or higher are eligible. 2. Meibomian gland dysfunction-associated dry eye will be diagnosed based on the following criteria: 1) Dry eye symptoms have persisted for at least 3 months prior to enrollment in the clinical study. 2) The tear break-up time is less than 10 seconds, and at least one of the following three criteria must be met: a. When pressure is applied to the eyelids, there is a reduction in the secretion of the meibomian glands, resulting in cloudy or toothpaste-like secretions, or viscous secretions. b. There are two or more instances of telangiectasia on the eyelid margins. c. Two or more meibomian gland openings are blocked.
Exclusion criteria
Exclusion criteria: Subjects with a medical history or medication that may interfere with the analysis of the treatment effects of dry eye, or who are deemed at high risk for complications or adverse events during controlled pulse light therapy and RF treatment, will be excluded. The following criteria will result in exclusion: 1. Individuals with a history of Sjögren's syndrome or uncontrolled rheumatic disease. 2. Individuals who have used Cyclosporine, steroids, or antibiotics (eye drops) within 2 weeks prior to the examination. 3. Individuals who have used lipid-containing eye drops (e.g., Liposic, ointments) within 2 weeks prior to the examination. 4. Individuals who have worn contact lenses within 4 weeks prior to the examination. 5. Individuals with a history of ophthalmic surgery or trauma within the last 3 months. 6. Individuals planning to undergo eye surgery (including LASIK/LASEK) during the study period. 7. Pregnant or breastfeeding women and female patients who plan to become pregnant. 8. Individuals with photosensitivity. 9. Individuals with a pacemaker or any metal implants in their body. 10. Individuals with allergies to fluorescein or topical anesthetics. 11. Individuals taking systemic medications that may affect lipids (e.g., tetracycline derivatives, antihistamines, isotretinoin, vitamin A). However, those taking antihyperlipidemic agents such as statins can be enrolled in the clinical study while maintaining their current dosage without changes during the study period. 12. Individuals with active infections of the eyelids or anterior segment, uncontrolled ophthalmic allergies (e.g., atopic keratoconjunctivitis), autoimmune diseases (e.g., graft-versus-host disease), a history of malignant tumors in the eyelids or ocular area, history of herpes or shingles keratitis, and other ocular structural anomalies (e.g., aniridia). 13. Individuals with contraindications for controlled pulse light therapy: active infections, dysplastic nevi, tattoos, significant comorbid skin conditions or inflammatory skin conditions, active herpes labialis, lacerations or abrasions, chronic or active viral, fungal, or bacterial infections, recent exposure to the sun or tanning beds 3-4 weeks prior to treatment, history or presence of skin cancer or precancerous lesions at the treatment site, and individuals classified as Goldman-Fitzpatrick Skin Type V. 14. Individuals with contraindications for RF treatment: patients with implanted pacemakers, internal defibrillators, implanted neurostimulators, or other internal devices (especially if it is not confirmed that all leads from past implants have been completely removed), metal implants or other implants in the treatment area, pregnant, breastfeeding, or menstruating individuals, current or past history of cancer (especially skin cancer or precancerous conditions), immunosuppressive diseases such as AIDS or HIV, significant medical conditions like heart disease or seizures, individuals whose conditions may be negatively affected by heat, individuals with exaggerated or diminished sensation to temperature changes, individuals at risk of inflammation, bleeding, or hemorrhage in the treatment area, septic conditions, psoriasis, eczema, rashes, or any active conditions of the treatment area such as excessive sunburned skin, varicose veins, keloid scars, abnormal wound healing, very dry and fragile skin, individuals scheduled for surgical or invasive procedures in the treatment area before the completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear-film break-up time;Ocular surface disease index | — |
Secondary
| Measure | Time frame |
|---|---|
| Fluorescein Corneal staining score;Lissamine green conjunctival staining score;Lipid layer thickness;Meibomian gland dysfjunction grade | — |
Countries
Korea, Republic of
Contacts
Public ContactSook Hyun Yoon
Daegu Catholic University Medical Center
Outcome results
None listed