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Development and Application of a Multimodal Intelligent Dry Eye Screening System Based on Mobile Devices

Development and Application of a Multimodal Intelligent Dry Eye Screening System Based on Mobile Devices

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119205
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Dry eye

Interventions

Mild Dry Eye Subgroup (Stage 1):None
Moderate Dry Eye Subgroup (Stage 1):None
Severe Dry Eye Subgroup (Stage 1):None
Healthy Control Subgroup (Stage 1):None
Mild Dry Eye Subgroup (Stage 2):None
Moderate Dry Eye Subgroup (Stage 2):None
Severe Dry Eye Subgroup (Stage 2):None
Healthy Control Subgroup (Stage 2):None
Mild Dry Eye Subgroup (Stage 3):None
Moderate Dry Eye Subgroup (Stage 3):None
Severe Dry Eye Subgroup (Stage 3):None
Healthy Control Subgroup (Stage 3):None

Sponsors

Eye & ENT Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the dry eye group: 1. Age 18–75 years old; 2. Diagnosed with dry eye according to the "Chinese Expert Consensus on Dry Eye (2024)"; 3. Voluntary participation in the study and signing of the informed consent form. Inclusion criteria for the control group: 1. Age 18–75 years old; 2. No history of dry eye or any related subjective symptoms (such as dryness, foreign body sensation, burning sensation, etc.); 3. TBUT > 10 seconds, and corneal fluorescein staining is negative; 4. Voluntary participation in the study and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Having a history of eye allergy or infection within the past 1 month; 2. Allergic to fluorescein sodium; 3. Excessive eyelid relaxation, incomplete eyelid closure, ectropion / entropion, palpebral fissure spots, pterygium or corneal conjunctival scars, and other diseases that affect blinking / closing of the eyes; 4. IOP of any eye > 21 mmHg in the current examination, or a history of glaucoma / high intraocular pressure in the past, or currently receiving anti-glaucoma medication; 5. Severe / serious eye diseases that the researcher judges may interfere with the assessment or compliance; 6. Severe / serious systemic diseases or uncontrolled medical conditions (such as uncontrolled diabetes) that the researcher judges may interfere with the assessment or compliance; 7. Unable / unwilling to cooperate with the research process, such as eye examination, questionnaire filling, or image collection, or having cognitive / comprehension deficiencies.

Design outcomes

Primary

MeasureTime frame
Area Under the ROC Curve;

Secondary

MeasureTime frame
Sensitivity;Specificity;Accuracy;

Countries

China

Contacts

Public ContactHong Jiaxu

Eye & ENT Hospital of Fudan University

jiaxu.hong@fdeent.org+86 21 6437 7134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026