Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients With Dry E… (NCT07060131) | Clinical Trial Compass
CompletedNot Applicable
Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients With Dry Eye Syndrome
Taiwan31 participantsStarted 2024-03-21
Plain-language summary
Dry eye disease (DED) is a multifactorial ocular surface condition characterized by instability of the tear film. DED is common in ophthalmic and optometric clinical practice, and meibomian gland dysfunction (MGD) has been identified as a major cause of evaporative DED. The use of heated eye mask is a common recommendation in the treatment of MGD, aiming to adequately heat the meibum to increase its liquefaction and flow. Several products are available for this purpose (e.g., Bruder Moist Heat Eye Compress \[Bruder Healthcare Company\], EyeGiene® \[Eyedetec Medical\], Blepha EyeBag® \[formerly MGDRx EyeBag, Théa Pharmaceuticals Ltd\], Blephasteam® \[Théa Pharmaceuticals Ltd\]).
This study employs far-infrared eye masks on the acupoints around the eyes, including Jingming, Taiyang, Sibai, Tongziliao, and Si Zhu Kong to assess whether there is an improvement in the symptomatic indicators of dry eye disease.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\*Clinical diagnosis of Dry Eye Disease by Ocular Surface Disease Index (OSDI) ≥ 13 and NIBUT \<10 seconds.
Exclusion Criteria:
* Eye inflammation
* Eyelid malposition, such as entropion, ectropion, and upper eyelid ptosis
* Recent eye surgery (within 3 months)
* Risks of retinal detachment such as high myopia, lattice degeneration, and retinal holes
* Use anti-inflammatory eye drops (topical steroids or cyclosporine) within 1 month
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a far infrared eye mask on acupoints around the eyes — how does stimulating those specific pressure points differ from a regular warm compress, and is there any reason to think that difference matters for my type of dry eye?
2The trial measured things like tear film break-up time, meibomian gland loss, and the OSDI symptom score — based on those particular outcomes, what would the results need to show to actually be meaningful for someone in my situation?
3Since this study is now completed, have you seen or can you find the published results, and do they suggest the far infrared mask performed better than standard dry eye treatments I might already be a candidate for?
4The Schirmer test and meibomian gland loss were both measured here — given that my dry eye may involve one more than the other, do you think a treatment targeting acupoints around the eyes would even address my specific underlying cause?
5Before considering a device like this, would it make sense for me to try established first-line treatments first, and how would we know if this kind of approach is worth adding to my care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Two-tailed Paired T-test of Persons with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _OSDI
Timeframe: 2 years
2
Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _NIBUT(non-invasive break-up time)
Timeframe: 2 years
3
Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Meibomian Gland Loss
Timeframe: 2 years
4
Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Schirmer test