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

NCT07060131 | Completed

• 1 other identifier: CMUH113-REC1-054
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease (DED)

Keywords

Far Infrared Eye Masks; Dry Eye Disease; Acupoints Around the Eyes

Outcome Measures

Primary Outcomes (4)

• Two-tailed Paired T-test of Persons with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _OSDI

  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.

  2 years

• Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _NIBUT(non-invasive break-up time)

  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.

  2 years

• Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Meibomian Gland Loss

  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.

  2 years

• Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Schirmer test

  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.

  2 years

Study Arms (1)

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

EXPERIMENTAL

Device: Far Infrared Eye Masks

Interventions

Far Infrared Eye Masks 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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*Clinical diagnosis of Dry Eye Disease by Ocular Surface Disease Index (OSDI) ≥ 13 and NIBUT \<10 seconds.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, North Dist, 404, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 32968960 BACKGROUND

• 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.

  PMID: 36856980 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: July 11, 2025
• Study Start: March 21, 2024
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

TW (1)