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Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients With Dry Eye Syndrome

C

China Medical University

Status

Enrolling

Conditions

Dry Eye Disease (DED)

Treatments

Device: Far Infrared Eye Masks

Study type

Interventional

Funder types

Other

Identifiers

NCT07060131
CMUH113-REC1-054

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients with DED
Experimental group
Treatment:
Device: Far Infrared Eye Masks

Trial contacts and locations

2

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Central trial contact

Yu-Chen Lee, M.D. & Ph.D.

Data sourced from clinicaltrials.gov

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