The Safety and Efficacy of Electronic Moxibustion for Dry Eye

The Safety and Efficacy of Electronic Moxibustion 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

KCT0006686

Enrollment

Registered

2021-10-25

Start date

2021-06-24

Completion date

Unknown

Last updated

2021-11-02

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 : 30 dry eye syndrome patients are randomly divided into both groups. 15 patients are allocated to an electronic moxibustion group, which is the experimental group. T

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 problems. 2. Irritated eye caused by acute inflammation arose from eyelid, eyeball, or ocular adnexa. 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 adnexa. 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. Administering systemic corticosteroids or immunosuppressants. 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 symtoms;Quality of life;Schirmer ? test;General assessment	—

Countries

Korea, Republic of

Contacts

Public ContactJi-Hoon Song

Dongshin University

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

Outcome results