Acupoint Therapy Device for Dry Eye

Tongji University

Status: Completed

Conditions: Dry Eye

Treatments: Device: dry eye acupoint therapy instrument; Drug: Artificial tear

Study type: Interventional

Funder types: Other

Identifiers

NCT06720428

YNCR2B003

Details and patient eligibility

About

To built a dry eye acupoint therapeutic instrument by stimulating acupoints with low impulse current .And the safety of the dry eye acupoint treatment device will be tested and the initial validation will be verified.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients who meet the diagnostic criteria for dry eye: The diagnostic and classification criteria refer to the Consensus of Chinese dry eye Experts: Definition and Classification (2020);
2. this study included patients with dry eyes can be treated as usual or are using artificial tears, also can be never accepted artificial tears treatment;
3. this research project, informed consent and signed informed consent form, participants are willing to accept treatment.

Those who met the above criteria could be included in the study.

Exclusion criteria

1. Patients with other eye diseases, acute inflammation or allergy of the eye or skin around the eye: such as blepharitis, lacrimal duct obstruction, congenital absence or dysplasia of lacrimal gland, anterior ganglia inflammation, such as trachoma, chemical burn and other corneal and conjunctival lesions, extensive scar of the eyelid conjunctival, long-term use of anti-glaucoma eye drops for glaucoma;
2. Those who have undergone external or internal eye surgery in the past 6 months；
3. Patients who have undergone tear punctum embolization or submandibular gland transplantation;
4. Wearing contact lenses within the past 3 months； （5）History of ocular trauma; （6）Active fundus lesions in the past 3 months； （7）People who are allergic to artificial tears; （8）Suffering from diseases that affect tear secretion, such as facial paralysis, diabetes, and hyperthyroidism;

(9)Patients with serious life-threatening primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system diseases, as well as mental illness; (10)Attending other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Dry eye acupoint therapy instrument treatment group One

Experimental group

Description:

Dry eye acupoint therapy instrument treatment group One was treated with instrument twice a week, at least two day apart, each time lasting 30 minutes. Treatment points include Jingming, Cunzhu, Si Zhukong , Sun , Sibai and Chengqi.

Treatment:

Drug: Artificial tear

Device: dry eye acupoint therapy instrument

Dry eye acupoint therapy instrument treatment group Two

Experimental group

Description:

Dry eye acupoint therapy instrument treatment group Two had the same treatment method with different treatment parameters.

Treatment:

Drug: Artificial tear

Device: dry eye acupoint therapy instrument

Artificial tear treatment group

Active Comparator group

Description:

The artificial tear treatment group was treated with artificial tear (Ali eye drops) four times a day.

Treatment:

Drug: Artificial tear