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Clinical study of arrayed microneedle in the treatment of dry eye

Clinical study of arrayed microneedle in the treatment of dry eye

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078187
Enrollment
Unknown
Registered
2023-11-30
Start date
2024-03-21
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

dry eye

Interventions

Arrayed microneedle + artificial tear group:Arrayed microneedle treatment with artificial tear
Sham needle + artificial tear group:Sham needle treatment with artificial tear
Artificial tear group:Pure artificial tear

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.People aged between 18 and 80 years old; 2.Gender is not limited; 3.Simultaneously meeting the diagnostic criteria of traditional Chinese medicine and Western medicine for dry eye; 4. with other diseases that do not require special treatment ; 5. Sign a written informed consent and volunteered to participate in the experimental study ; 6.Willing to comply with all test requirements.

Exclusion criteria

Exclusion criteria: 1. Those who used artificial tears within 2 weeks ; 2.Those with active inflammatory diseases such as conjunctivitis and iritis within 1 month ; 3.Those who had cataract extraction, anti-glaucoma and other intraocular surgery, corneal laser surgery, ocular surface pterygium excision and other external eye surgeries within 3 months ; 4. Those with nasolacrimal duct obstruction and eyelid absence ; 5.Those with local skin ulcer, abscess,inflammation, etc. in the related treatment sites; 6. Those allergic to medical tapes; 7.Those with psychiatric disorders; 8.Those with systemic immune diseases ; 9.Participated in other clinical trials within the past month.

Design outcomes

Primary

MeasureTime frame
Subjective symptom score;

Secondary

MeasureTime frame
Ocular surface disease index;Chinese Dry Eye Questionnaire Scale;Schirmer I Test;Tear film break-up time;Corneal fluorescence stain;Daily use frequency of artificial tear;Effective rate;Intra-ocular tension;Best corrected visual acuity;

Countries

China

Contacts

Public ContactShifen Xu

Shanghai Municipal Hospital of Traditional Chinese Medicine

xu_teacher2006@126.com+86 137 6193 1393

Outcome results

None listed

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