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

NCT ID: NCT07060131

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye Disease (DED)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients with DED

Group Type EXPERIMENTAL

Far Infrared Eye Masks

Intervention Type DEVICE

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.

Interventions

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Far 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China Medical University Hospital

Taichung, North Dist, Taiwan

Site Status RECRUITING

China Medical University Hospital

Taichung, North Dist, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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

Role: CONTACT

886-4-2205-2121 Ext. 1670

Facility Contacts

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Yu-Chen Lee, Ph.D

Role: primary

+886-975-682-023

References

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Valencia-Nieto L, Novo-Diez A, Blanco-Vazquez M, Lopez-Miguel A. Therapeutic Instruments Targeting Meibomian Gland Dysfunction. Ophthalmol Ther. 2020 Dec;9(4):797-807. doi: 10.1007/s40123-020-00304-3. Epub 2020 Sep 24.

Reference Type BACKGROUND
PMID: 32968960 (View on PubMed)

Sheppard JD, Nichols KK. Dry Eye Disease Associated with Meibomian Gland Dysfunction: Focus on Tear Film Characteristics and the Therapeutic Landscape. Ophthalmol Ther. 2023 Jun;12(3):1397-1418. doi: 10.1007/s40123-023-00669-1. Epub 2023 Mar 1.

Reference Type BACKGROUND
PMID: 36856980 (View on PubMed)

Other Identifiers

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CMUH113-REC1-054

Identifier Type: -

Identifier Source: org_study_id

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