Acupoint Therapy Device for Dry Eye

Development of a Prototype of Acupoint Therapy Device for Dry Eye and Preliminary Verification of Its Clinical Efficacy

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: dry eye acupoint therapy instrument; Drug: Artificial tear

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 270002
      • Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: dry eye acupoint therapy instrument; The dry eye acupuncture point treatment device treat dry eye through stimulating acupuncture points by low pulse current.; Drug: Artificial tear; 0.3% Ali eye drops
Experimental: 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.	Device: dry eye acupoint therapy instrument; The dry eye acupuncture point treatment device treat dry eye through stimulating acupuncture points by low pulse current.; Drug: Artificial tear; 0.3% Ali eye drops
Active Comparator: Artificial tear treatment group; The artificial tear treatment group was treated with artificial tear (Ali eye drops) four times a day.	Drug: Artificial tear; 0.3% Ali eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MGD	Meibomian Gland (MG) expressibility and secretion quality	baseline and 8 weeks post-treatment

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Validity; Acupuncture treatment; Dry Eye Acupoint Therapeutic Instrument
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions; Lubricant Eye Drops
• Other Study ID Numbers: YNCR2B003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No