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Completed

NCT Number: NCT06720428

Acupoint Therapy Device for Dry Eye

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 270002, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

dry eye acupoint therapy instrument

Device

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

Artificial tear

Drug

0.3% Ali eye drops

Primary outcomes

  1. Schirmer's test (SLT)

    Time frame: baseline and 8 weeks post-treatment

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

  2. Tear film breakup time (TBUT)

    Time frame: baseline and 8 weeks post-treatment

    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.

  3. Ocular Surface Disease Index, OSDI

    Time frame: baseline and 8 weeks post-treatment

    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

  4. Corneal fluorescein staining (CFS)

    Time frame: baseline and 8 weeks post-treatment

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

Secondary outcomes

  1. MGD

    Time frame: baseline and 8 weeks post-treatment

    Meibomian Gland (MG) expressibility and secretion quality

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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