The Safety and Efficacy of Intradermal Acupuncture for Dry Eye

The Safety and Efficacy of Intradermal Acupuncture for Dry Eye: An Investigator-initiated, Assessor-blinded, Randomized Controlled Parallel Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006231

Enrollment

Registered

2021-06-08

Start date

2021-03-10

Completion date

Unknown

Last updated

2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Through randomization, 30 dry eye syndrome patients are equally divided into intradermal acupuncture group, which is the experimental group, and body acupuncture gr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants should satisfy all following criteria; 1. Male and female patients aged 19-65 at the screening visit. 2. Patients who have typical dry eye symptoms including pruritus, foreign body sensation, pain, dryness, blurry eye, dazzle, eye congestion, and illacrimation. 3. Patients who are diagnosed dry eye syndrome by more than 13 score in the Ocular Surface Disease Index. 4. Patients who submitted written consent voluntarily.

Exclusion criteria

Exclusion criteria: Patients who satisfy any criterion of the followings cannot participate in this study; 1. Dry eye syndrome caused by eyelid or eyelashes. 2. Irritated eye caused by acute inflammation arose from eyelid, eyeball, or ocualr appendage. 3. Diagnosed as skin diseases including Stevens-Johnson syndrome, pemphigoid, or etc. 4. Diagnosed as vitamin A deficiency. 5. Patients who have damages caused by injury of eyeball or ocular appendage. 6. Patients who had operation to anterior segment of the eye or operation via anterior eye including cataract or LASIK within recent 3 months. 7. Have a difficulty in blink because of facial palsy. 8. Received punctal plug or punctal occlusion. 9. Used anti-inflammatory drops including cyclosporine, corticosteroids, or autoserotherapy directly to the eye within recent 2 weeks. 10. Receiving systemic corticosteroids or immunosuppressants treatment. 11. Pregnant, lactating women, or women planning pregnancy. 12. Other cases which investigators determined inadequate.

Design outcomes

Primary

Measure	Time frame
Ocular Surface Disease Index(OSDI)	—

Secondary

Measure	Time frame
Visual analogue scale for subjective symptom;Quality of life;Schirmer ? test;Patient's general assessment;Investigator's general assessment	—

Countries

Korea, Republic of

Contacts

Public ContactJi-Hoon Song

Dongshin University

kmdsjh0122@nate.com+82-61-338-7811

Outcome results