CompletedNot Applicable

Acupoint Therapy Device for Dry Eye

China120 participantsStarted 2021-01-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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;

What they're measuring

Schirmer's test (SLT)

Timeframe: baseline and 8 weeks post-treatment

Tear film breakup time (TBUT)

Timeframe: baseline and 8 weeks post-treatment

Ocular Surface Disease Index, OSDI

Timeframe: baseline and 8 weeks post-treatment

Corneal fluorescein staining (CFS)

Timeframe: baseline and 8 weeks post-treatment

Trial details

NCT IDNCT06720428

SponsorShanghai 10th People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Dry Eye trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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;

What they're measuring

Schirmer's test (SLT)

Timeframe: baseline and 8 weeks post-treatment

Tear film breakup time (TBUT)

Timeframe: baseline and 8 weeks post-treatment

Ocular Surface Disease Index, OSDI

Timeframe: baseline and 8 weeks post-treatment

Corneal fluorescein staining (CFS)

Timeframe: baseline and 8 weeks post-treatment