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A Comparative Study on the Efficacy and Safety of Biodegradable Microneedle Acupunture and Conventional Intradermal Acupuncture for Dry Eye

A Comparative Investigator-initiated Pilot study on the Efficacy and Safety of Biodegradable Microneedle Acupuncture and Conventional Intradermal Acupuncture for Dry Eye Patient: A Superiority, Assessor-blinded, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007358
Enrollment
30
Registered
2022-06-08
Start date
2022-07-06
Completion date
Unknown
Last updated
2024-08-19

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 : Thirty dry eye patients are randomly divided into the biodegradable microneedle acupuncture group and the intradermal acupuncture group. For 4 weeks, the interventions are treated 3 t

Sponsors

Naju Dongshin University Korean Medicine Hospital
Lead Sponsor

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, and whose Ocular Surface Disease Index score is more than 13. 3. Less than 10 mm/5 min in Schirmer ? test. 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. Patients who have active ocular infections including anterior uveitis or anterior blepharitis. 11. Patients who have ocular allergy or who are receiving treatments for allergic eye diseases. 12. Patients who have viral conjunctivitis symptoms or who are receiving treatments for viral conjunctivitis. 13. Patients whose intraocular pressure is more than 25 mmHg in a single eye or both eyes, or who are diagnosed as glaucoma. 14. Receiving systemic corticosteroids or immunosuppressants treatment. 15. Pregnant, lactating women, or women planning pregnancy. 16. Other cases which investigators determined inadequate.

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index(OSDI)

Secondary

MeasureTime frame
Visual analogue scale for subjective symptoms;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

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026