MedPath

Evaluation of the effectiveness and safety of bianshi moxibustion infrared dry eye therapeutic instrument in the treatment of meibomian gland dysfunctio

Phase 1
Conditions
meibomian gland dysfunction
Registration Number
ITMCTR1900002769
Lead Sponsor
Peking University Third Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Aged 18~80 years old;
2. Diagnostic criteria of dry eye:
(1) Ocular symptoms:
1) Feeling dry eye every day for more than 3 months;
2) Repeated foreign body sensation;
3) Using artificial tears more than 3 times one day;
(2) Ocular signs:
1) Schirmer I test (ST-I)(no anesthesia) <=5mm / 5min;
2) Corneal fluorescein staining score >=4 (according to van Bijsterveld scoring standard);
The diagnosis of dry eye requires at least one symptom and one sign.
3. Diagnostic criteria of meibomian gland dysfunction
(1) Absence of meibomian glands;
(2) Abnormal of eyelid margin and meibomian gland;
(3) Changes in the quantity and quality of meibomian secretion;
MGD could be diagnosed with any of these signs in combination with dry eye symptoms.

Exclusion Criteria

(1) Caused by systemic diseases (pain, fever, cough) or other external environmental factors.
(2) Complicated with other eye diseases (glaucoma, cataract, retinal detachment, etc.) or undergone eye surgery.
(3) Systemic connective tissue disease or severe autoimmune diseases
(4) Patients with central nervous system disease or craniocerebral surgery.
(5) Patients with severe diseases of heart, lung, liver, kidney or blood system.
(6) Patients who suspect or have a history of alcohol or drug abuse or mental illness.
(7) Allergic constitution.
(8) Pregnant or lactating women.
(9) Patients who have taken medication for dry eye in the last 2 weeks.
(10) Patients who have participated in other clinical trials within the last 1 month or have accepted the randomized group of this clinical trial.
(11) The investigator considers that the participants are not suitable for this clinical trial.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Eyelid margin score;Corneal fluorescein staining score;Ocular Surface Disease Index;Tear break up time;Schirmer I test;Tear meniscus height;Meibomian gland score;
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath