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Clinical trial study on the effectiveness of far-infrared functional glasses in the treatment of dry eye

Clinical trial study on the effectiveness of far-infrared functional glasses in the treatment of dry eye

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079099
Enrollment
Unknown
Registered
2023-12-25
Start date
2022-04-25
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dry eye

Interventions

experimental group:Wear far-infrared functional glasses throughout the day (wear when awake, take them off when sleeping)

Sponsors

Beijing Tongren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Voluntarily participate in this clinical study and sign informed consent. (2) Gender is not limited, age 18-70 years old. (3) There are clinical symptoms and signs of dry eye, clinical examination can be diagnosed as meibomian gland dysfunction related dry eye: When patients meet the diagnostic criteria for both dry eye and meibomian gland dysfunction, they are diagnosed with meibomian gland dysfunction associated dry eye Dry eye was diagnosed according to TFO Dews II (2017 edition) : (1) Symptoms: Ocular Surface Disease Index (OSDI) questionnaire =13 points or dry eye Severity scale (VAS)=6 points; (2) At least one positive result of the following steady state markers: fluorescein tear film rupture time =10s, tear osmotic pressure difference between eyes or eyes > 8mOsm/L, eye surface staining: corneal staining points > 5, conjunctiva staining spots > 9, or colored eyelid edges [=2 mm length &=25% width]. According to the MGD International Symposium, meibomian gland dysfunction can be diagnosed as: (1) Clinical signs: meibomian gland detachment, meibomian gland secretion changes and morphological changes; (2) General discomfort symptoms, such as redness, swelling, itching, irritation, and soreness. (4) Corneal fluorescein does not stain or spot coloring, the coloring points are countable (and the staining number is less than 30 points) and conjunctival fluorescein staining 0-? grade; (4) corneal fluorescein without staining or dot staining countable (and the number of staining =30 points) and conjunctival fluorescein staining 0-? grade; (5) Did not participate in other clinical trials within 2 weeks of the trial. (6) are not using other treatments for dry eye, or are using other treatments but have stopped for more than 2 weeks.

Exclusion criteria

Exclusion criteria: Any one of the following circumstances is not considered as an enrolled case: (1) Pregnant or lactating women or those who have a family plan recently. (2) Patients with other eye diseases. (3) Tear film rupture time =0 seconds, or tear secretion experiment =0 mm /5 minutes. (4) Total corneal staining is greater than 30 points, there are flaky coloring fusion or filamentous objects. (5) Patients with severe MGD (grade 4). (6) Complicated with serious primary disease of heart, cerebrovascular, liver, kidney and hematopoietic system. (7) Internal eye surgery or external eye injuries within the last six months. (8) Patients who could not stop wearing contact lenses during the test. (9) Long-term systemic or ocular medication may affect patients evaluated in the study. (10) The required use of equipment and visitors cannot be guaranteed during the test. (11) Sjogren's syndrome, systemic diseases, and other eye diseases that affect the evaluation of efficacy. (12) Those who have any reasons that the researcher deems unsuitable for participating in the experiment.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;breakup time of tear film;OSDI scores;

Secondary

MeasureTime frame
Schirmer test;Evaluation of meibomian glands;

Countries

China

Contacts

Public ContactTian Lei

Beijing Tongren Hospital

tianlei0131@163.com+86 135 1102 6669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026