Acupoint Therapy Device for Dry Eye

NCT ID: NCT06720428

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye

Keywords

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Acupuncture treatment Dry Eye Acupoint Therapeutic Instrument Safety Validity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Dry eye acupoint therapy instrument treatment group One

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.

Group Type EXPERIMENTAL

dry eye acupoint therapy instrument

Intervention Type DEVICE

The dry eye acupuncture point treatment device treat dry eye through stimulating acupuncture points by low pulse current.

Artificial tear

Intervention Type DRUG

0.3% Ali eye drops

Dry eye acupoint therapy instrument treatment group Two

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

Group Type EXPERIMENTAL

dry eye acupoint therapy instrument

Intervention Type DEVICE

The dry eye acupuncture point treatment device treat dry eye through stimulating acupuncture points by low pulse current.

Artificial tear

Intervention Type DRUG

0.3% Ali eye drops

Artificial tear treatment group

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

Group Type ACTIVE_COMPARATOR

Artificial tear

Intervention Type DRUG

0.3% Ali eye drops

Interventions

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dry eye acupoint therapy instrument

The dry eye acupuncture point treatment device treat dry eye through stimulating acupuncture points by low pulse current.

Intervention Type DEVICE

Artificial tear

0.3% Ali eye drops

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jing Yu

Director, Ophthalmology, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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YNCR2B003

Identifier Type: -

Identifier Source: org_study_id