meibomian gland dysfunction
Conditions
Interventions
iLUX Group:iLUX treatment
Control Group:warm compress and MGX
Sponsors
Xiamen eye center of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Common inclusion criteria for each cohort ? 18 years of age or older, and under 55 years old ? Diagnosed with MGD who meet either of the following two criteria: Altered meibum quality (grade>=1 and =1 and <=3; expressibility is assessed on a scale of 0 to 3 in five glands of the central of the lower eyelids according to the number of glands expressible. Grade 1: three to four glands; Grade 2: one to two glands; Grade 3: no glands) ? A history of MGD symptoms for 3 months prior to study enrollment, demonstrated by baseline SPEED scores equal or greater than 6 ? Agreement/ability to not start other MGD medications for the duration of the study ? Patients must be willing and able to participate in all study treatments, visits and assessments.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: ? Meibomian glands loss of >2/3 at screening as evaluated using meibography ? Demodex blepharitis ? Severe blepharokeratoconjunctivitis ? Previous IPL, Lipiflow or Systane iLUX treatment within 6months ? Warm massage or warm expression treatment within 4 weeks before enrollment ? Active skin lesions, basal cell carcinoma or other skin cancers, folliculitis, facial skin grafts ? A history of ocular surgery or isotretinoin (e.g. Accutane) use within the past year; ocular trauma, herpetic keratitis, or recurrent ocular inflammation within the past 3 months, with puncta plugs or puncta occlusion ? Fluctuations in systemic or ophthalmic medication dose, or start a new regimen of systemic medication known to cause dry eye (e.g., antihistamines, antidepressants, antipsychotics, benzodiazepines ) or meibomian gland dysfunction ophthalmic medications ? Use of another investigational device or agent within the past month ? Systemic disease conditions that cause dry eye (e.g., Sjogren syndrome), pregnancy, or lactation ? Active ocular infection, anterior blepharitis, lid abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function, limbal stem cell deficiency, ocular/eyelid cicatricial disease or eyelid tattoos (including permanent eyeliner makeup) ? Patients will be also excluded if they take cyclosporine A or lifitegrast ophthalmic solution 5% or any other dry eye or meibomian gland dysfunction medications (such as Omega 3 supplements, lipid-based eye drops) within 1 month before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Meibomian gland secretion (MGS) score;Meibum expressibility score (MES); | — |
Secondary
| Measure | Time frame |
|---|---|
| Meibum quality score (MQS);Orifices plugging score (OPS);Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire;Tear breakup time (TBUT);Corneal fluorescein staining (CFS); | — |
Countries
China
Contacts
Public ContactZuguo Liu
Xiamen eye center of Xiamen University
Outcome results
None listed