Meibomian gland dysfunction H02.8
Conditions
Interventions
Group 1: Patients with meibomian gland dysfunction (MGD) treated with the E>Eye Intense Pulsed Light (IPL) system from E-SWIN
The treatment is carried out as part of routine clinical practice. Patient
Sponsors
Afideara GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: At least 5 non-atrophic glands in the lower eyelid of each eye Current diagnosis of moderate to severe MGD in both eyes, including 2 of the following 5 criteria: o Tear break-up time (TBUT) = 10 seconds in both eyes; o Meibomian gland (MG) score (using the abbreviated MGD scoring system for clinical trials [1]) = 11 in both eyes o Corneal fluorescein staining (CFS) score (using the Baylor grading scheme [2]) = 10 in both eyes; o Tear osmolarity = 310 milliosmol/L in both eyes or a difference of more than 8 milliosmol/L between both eyes o VELOCITY = 10
Exclusion criteria
Exclusion criteria: - Eye surgery or eyelid surgery within the last 6 months - Neuroparalysis in the planned treatment area within the last 6 months - Other uncontrolled eye diseases affecting the ocular surface - Current use of punctal plugs - Precancerous or pigmented lesions or skin cancer in the treatment area - Uncontrolled infections or uncontrolled immunosuppressive diseases - Laser in situ keratomileusis (LASIK) surgery within the last 6 months - Herpes simplex 1 and 2, systemic lupus erythematosus, porphyria - Use of photosensitive medications and/or herbs, - Excessive sun exposure within the last 4 weeks - Pregnancy and breastfeeding - Prescription eye drops for dry eyes - Radiation therapy to the head or neck - chemotherapeutic agent - Blindness as defined by law in at least one eye - History of migraine, seizures or epilepsy - Lipiflow treatment within the last 12 months - Expression of the Meibomian glands within the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| How does the tear film break-up time in seconds change using the standard fluorescein staining method [compared to baseline] and how do the corneal fluorescein staining score (Baylor scheme) and Meibomian gland score (MGD grading system) develop? | — |
Secondary
| Measure | Time frame |
|---|---|
| Do subjective symptoms, assessed using the SPEEDs questionnaire and subjective pain/discomfort level, decrease significantly? After how many treatments do the symptoms become less severe? Are immediate/short-term skin reactions observed? Can the necessary concomitant medication be reduced? | — |
Countries
Germany
Contacts
Public ContactChristian Brinkmann
Dietrich Bonhoeffer Klinikum
Outcome results
None listed