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A prospective, multi-center, randomized, and controlled clinical trial to evaluate the effectiveness and safety of intense pulsed light and laser system (M22) in dry eye patients caused by meibomian gland dysfunction (MGD) compared to basic physical therapy

A prospective, multi-center, randomized, and controlled clinical trial to evaluate the effectiveness and safety of intense pulsed light and laser system (M22) in dry eye patients caused by meibomian gland dysfunction (MGD) compared to basic physical therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014787
Enrollment
Unknown
Registered
2018-02-05
Start date
2017-12-01
Completion date
Unknown
Last updated
2018-02-12

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

Conditions

Dry eye disease

Interventions

Trial:Intense pulsed light and meibomian gland massage
Control:Hot compress and meibomian gland massage

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria (1) = 18 years of age; (2) Fitzpatrick skin type 1-4; (3) Standard dry eye questionnaire (SPEED) score = 6; (4) Meibomian gland function score = 12 ; (5) Tear film break-up time (TBUT) = 10 seconds *; (6) Corneal fluorescein staining score = 1; (7) The subjects must sign an informed consent form, willing to comply with the treatment and follow-up schedule, and participate voluntarily in this study. *Note: If TBUT =5 seconds, do not considerate criterion 6.

Exclusion criteria

Exclusion criteria: (1) Pregnancy and nursing; (2) Contact lens wearer; (3) Acute ocular inflammation or infection; (4) There is obvious scar or keratinization on the eyelid; (5) received eye surgery or eyelid surgery within 6 months prior to enrollment; (6) Neuroparalysis occurred in the treatment area within 6 months before enrollment; (7) Tear plug is being used; (8) precancerous lesions in the treatment area, skin cancer or pigmentation; (9) received LASIK surgery within 6 months prior to enrollment; (10) The treated area suffers from diseases that may be stimulated by light waves of 560 nm to 1200 nm, such as herpes simplex types 1 and 2, systemic lupus erythematosus and porphyria; (11) taking photosensitizers, such as isotretinoin, tetracycline or St. John's wort; (12) Eye drops for dry eye within 48 hours before enrollment (except for artificial tears); (13) The history of head and neck radiotherapy within 1 year before enrollment, or radiotherapy within 8 weeks after intensive pulsed light therapy is expected; (14) Chemotherapy history within the first 8 weeks of enrollment, or chemotherapy within 8 weeks after intense pulsed light therapy is expected; (15) history of migraine or epilepsy; (16) A face intense pulsed light treatment was performed within one year before enrollment. (17) excessive exposure in the first 4 weeks before enrollment; (18) Other conditions judged by the researcher as unsuitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
Tear break-up time;

Secondary

MeasureTime frame
Meibomian gland assessment;Standard patient evaluation of eye dryness;Corneal fluorescein staining;Standard vision;Intraocular pressure;Observation of palpebral margin and anterior segment;

Countries

China

Contacts

Public ContactXiaoming Yan

Peking University First Hospital

13501297605@163.com+86 13502197605

Outcome results

None listed

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