Dry Eye Disease (DED)
Conditions
Keywords
Far Infrared Eye Masks, Dry Eye Disease, Acupoints Around the Eyes
Brief 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.
Interventions
DEVICEFar Infrared Eye Masks
Using 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.
Sponsors
China Medical University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-tailed Paired T-test of Persons with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _OSDI | 2 years | OSDI is collected in scores All the data mentioned above will be collected before and after treatment one month later. They will be compared with two-tailed paired t-test separately. P \< 0.05 was considered statistically significant. |
| Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _NIBUT(non-invasive break-up time) | 2 years | NIBUT(non-invasive break-up time) recorded in sec will be collected before and after treatment 30 mins and one month later. They will be compared with two-tailed paired t-test separately. P \< 0.05 was considered statistically significant. |
| Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Meibomian Gland Loss | 2 years | Meibomian Gland Loss in percentage will be collected before and after treatment 30 mins and one month later . They will be compared with two-tailed paired t-test separately. P \< 0.05 was considered statistically significant. |
| Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Schirmer test | 2 years | Description: Schirmer test in mm. All the data mentioned above will be collected before and after treatment 30 mins and one month later. They will be compared with two-tailed paired t-test separately. P \< 0.05 was considered statistically significant. |
Countries
Taiwan
Outcome results
None listed