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Morphological characteristics of the outer transparent ring in tear crystals and their correlations with dry eye pathological indicators: Implications for graded diagnostic value

Morphological characteristics of the outer transparent ring in tear crystals and their correlations with dry eye pathological indicators: Implications for graded diagnostic value

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118954
Enrollment
Unknown
Registered
2026-02-13
Start date
2026-02-14
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Dry eye disease

Interventions

Healthy control group:No intervention is applied
only standardized tests consistent with those of other groups are performed.
Mild DED Group:No intervention is applied
Moderate DED Group:No intervention is applied
Severe DED Group:No intervention is applied

Sponsors

The First People's Hospital of Zigong City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: This study intends to recruit 136 subjects aged 50-70 years, with a 1:1 male-to-female ratio, and divide them into 4 groups (34 cases each) according to the severity of dry eye: the healthy control group, the mild dry eye group, the moderate dry eye group, and the severe dry eye group. Each group shall meet the corresponding inclusion criteria as follows: 1.The healthy control group requires an OSDI questionnaire score of = 10 seconds, a negative result (0 points) in corneal fluorescein staining (CFS, NEI grading method); 2.The mild dry eye group requires an OSDI questionnaire score of >= 13, a NIBUT of = 13, a NIBUT of = 13, a NIBUT of = 3 points, with visible fused lesions or diffuse staining), or accompanied by severe ocular surface symptoms and visual function impairment. All subjects must voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: All groups of subjects need to exclude the following conditions: 1. previous history of ocular chemical injury, thermal burn or eye surgery in recent 6 months; 2. wearing contact lenses in the past 1 month; 3. suffer from pterygium, acute conjunctivitis, active blepharitis and other ocular surface diseases that affect tear secretion; 4. suffering from severe uncontrolled systemic diseases such as Sjogren's syndrome, thyroid associated ophthalmopathy, uncontrolled diabetes, etc; 5. in the past two weeks, he has used ophthalmic drugs other than artificial tears or systemic drugs such as antihistamines and antidepressants that affect tear secretion; 6. during pregnancy or lactation; 7. unable to cooperate to complete relevant inspections; 8. and the minimum amount of tear required for detection cannot be collected in the non stimulated state (usually>10 µ L), or reflective tears are caused due to difficulties in collection, which seriously affects the physical and chemical properties of the sample.

Design outcomes

Primary

MeasureTime frame
Lipid Layer Thickness(LLT);Tear Osmolarity(Tosm);Area Ratio of Outer Transparent Ring in Tear Ferning Patterns;

Secondary

MeasureTime frame
Ocular Surface Disease Index Score(OSDI Score);Non-invasive Tear Break-up Time(NIBUT);Corneal Fluorescein Staining Score(CFS Score) ;Partial Blink Rate;Tear Meniscus Height;

Countries

China

Contacts

Public ContactChengzhang Luo;Shuangle Li

North Sichuan Medical College;The First People's Hospital of Zigong City

17311452024@163.com+86 173 1145 2024

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026