A Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Electroacupuncture and Its Cotreatment with Electronic Moxibustion for Dry eye syndrome

A Randomized, Assessor-blinded, Controlled, Parallel, Prospective, Investigator's Clinical Trial to Evaluate the Efficacy and Safety of Electroacupuncture and Its Cotreatment with Electronic Moxibustion for Dry eye syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009622

Enrollment

Registered

2024-07-10

Start date

2024-07-01

Completion date

Unknown

Last updated

2024-07-23

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 : The electroacupuncture-electronic moxibustion group will receive acupuncture treatment on the bilateral BL1, BL2, EX-HN5, GB1, TE23, LI4, SP6, KI3, and ST36 with 0.20 × 30 mm disposab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants should meet all of the following criteria: (1) Male or female patients aged 19-70 at the screening visit. (2) Patients with ocular surface disease index (OSDI) score of =13. (3) Patients with tear film break-up time (TFBUT) of = 10 seconds. (4) Patients who can read and write Korean and voluntarily submitted written consent with their signature.

Exclusion criteria

Exclusion criteria: Participants who have any of the following criteria are not eligible to participate in this study: (1) Patients with dry eye syndrome caused by eyelids or eyelashes. (2) Patients with Irritated eye caused by acute inflammation arising from the eyelid, eyeball, or ocular appendage. (3) Patients who wore contact lenses within the recent 2 weeks or who have to wear contact lenses during the trial period. (4) Patients who had an operation to the anterior segment of the eye or operation via the anterior eye including cataract or LASIK within recent 3 months. (5) Patients who used anti-inflammatory drops, including cyclosporine, corticosteroids, or autoserotherapy, directly to the eye, within recent 2 weeks. (6) Patients who are diagnosed with vitamin A deficiency. (7) Patients who have difficulty in blink due to facial palsy. (8) Patients who received punctal plug or punctal occlusion. (9) Patients who have damages caused by injury of the eyeball or ocular appendage. (10) Patients who have secondary dry eye syndrome due to scarring caused by irradiation, alkali burn, Stevens-Johnson syndrome, or cicatrical pemphigoid. (11) Patients who are receiving treatments for allergic ocular conditions or viral conjunctivitis. (12) Patients whose intraocular pressure is more than 25 mmHg in a single eye or both eyes or who are diagnosed with glaucoma. (13) Patients who have active ocular infections including anterior uveitis or anterior blepharitis. (14) Patients taking systemic corticosteroids or immunosuppressants. (15) Patients who have an implant in the body that is unsuitable for acupuncture treatment, including pacemaker and implantable defibrillator, or are sensitive to electroacupuncture treatment. (16) Pregnant, lactating women, or women planning pregnancy. (17) Others whom investigators determined ineligible.

Design outcomes

Primary

Measure	Time frame
Ocular surface disease index (OSDI);Tear film break-up time (BUT)	—

Secondary

Measure	Time frame
Visual analog scale (VAS) for subjective symptoms;Quality of life;Schirmer I test;General assessment	—

Countries

Korea, Republic of

Contacts

Public ContactJi-Hoon Song

Dongshin University

kmdsjh0122@nate.com+82-61-338-7858

Outcome results