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A clinical observational study to evaluate the accuracy, effectiveness, and reproducibility of the SMTube®

A multicenter, randomized, parallel-group, controlled clinical observational study to evaluate the accuracy, effectiveness, and reproducibility of the SMTube®

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076074
Enrollment
Unknown
Registered
2023-09-25
Start date
2023-09-25
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

Dry eye

Interventions

Dry eye Group:NA

Sponsors

Xiamen eye center of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age = 18 years, any gender. Clear understanding and voluntary participation in the study, with written informed consent signed by the individual, willing to follow all the experimental assessments as instructed. A) The inclusion criteria for the non-dry eye population (control group) are as follows: Does not meet (fails to meet) the diagnostic criteria for dry eye and has a healthy ocular surface without other diseases. B) Inclusion criteria for dry eye patients: According to the "Chinese Expert Consensus on Dry Eye: Examination and Diagnosis (2020)", patients complain of subjective symptoms such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, eye redness, fluctuating vision, with a Chinese Dry Eye Questionnaire score = 7 points or Ocular Surface Disease Index (OSDI) score = 13 points; at the same time, FBUT = 5s or NIBUT 5s and = 10s or NIBUT is between 10-12s, Schirmer I test (without anesthesia) is > 5 mm/5 min and = 10 mm/5 min, then corneal fluorescein staining should be performed, and positive staining (= 5 dots) can diagnose dry eye. Participants who use artificial tears should stop using them for at least 12 hours prior to the examination.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Any of the following criteria will result in the participant being ineligible for inclusion in this study: Floppy eyelid syndrome. Severe dry eye patients, especially those with severe aqueous deficiency. Severe blepharitis or severe meibomian gland dysfunction. History of lacrimal duct diseases such as lacrimal duct obstruction, dacryocystitis, or lacrimal plug surgery. History of ocular surgery within the past month. History of ocular or periocular malignant tumors. Dry eye caused by sequelae of scars (such as radiation, alkali burns, Stevens-Johnson syndrome, cicatricial pemphigoid) or destruction of conjunctival goblet cells (such as vitamin A deficiency). Acute phase of ocular allergy. Ocular or systemic infection (bacterial, viral, or fungal), including fever, herpetic keratitis, or undergoing antibiotic treatment. History of any immunodeficiency, HIV infection, hepatitis B, hepatitis C, acute active hepatitis A (positive anti-HAV IgM), organ or bone marrow transplantation. Any significant chronic diseases that the investigator deems may interfere with the study parameters.

Design outcomes

Primary

MeasureTime frame
SMTube;

Secondary

MeasureTime frame
The Chinese Dry Eye Questionnaire;ocular?surface?disease?index, OSDI; tear meniscus height;tear film break up time;redness;Fluorescein Staining;Schirmer I test;Eyelid mergin assessment;

Countries

China

Contacts

Public ContactLiu Zuguo

Eye Institute of Xiamen University

zuguoliu@xmu.edu.cn+86 189 5928 9999

Outcome results

None listed

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