Acupoint Therapy Device for Dry Eye

NCT06720428 | Completed

• 1 other identifier: YNCR2B003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye

Keywords

Acupuncture treatment; Dry Eye Acupoint Therapeutic Instrument; Safety; Validity

Outcome Measures

Primary Outcomes (4)

• Schirmer's test (SLT)

  The Schirmer test uses filter paper to wick up tears and measure the amount of production.

  baseline and 8 weeks post-treatment

• Tear film breakup time (TBUT)

  The time interval between keeping eyes open after blinking until the first dry spot appears on the tear film surface is one of the important criteria to evaluate the stability of tear film.

  baseline and 8 weeks post-treatment

• Ocular Surface Disease Index, OSDI

  The most commonly used questionnaire in clinical diagnosis of dry eye. It is mainly used to diagnose dry eye and assess the severity of the condition

  baseline and 8 weeks post-treatment

• Corneal fluorescein staining (CFS)

  Corneal fluorescein staining (CFS) is a valuable clinical tool to assess the viability of the epithelium.

  baseline and 8 weeks post-treatment

Secondary Outcomes (1)

• MGD

  baseline and 8 weeks post-treatment

Study Arms (3)

Dry eye acupoint therapy instrument treatment group One

EXPERIMENTAL

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.

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

Dry eye acupoint therapy instrument treatment group Two

EXPERIMENTAL

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

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

Artificial tear treatment group

ACTIVE COMPARATOR

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

Drug: Artificial tear

Interventions

dry eye acupoint therapy instrument DEVICE

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

Dry eye acupoint therapy instrument treatment group One; Dry eye acupoint therapy instrument treatment group Two

Artificial tear DRUG

0.3% Ali eye drops

Artificial tear treatment group; Dry eye acupoint therapy instrument treatment group One; Dry eye acupoint therapy instrument treatment group Two

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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;
• 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.

You may not qualify if:

• 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;
• Those who have undergone external or internal eye surgery in the past 6 months；
• Patients who have undergone tear punctum embolization or submandibular gland transplantation;
• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 270002, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Ophthalmology, Clinical Professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CN (1)