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Evaluation of the feasibility of applying internal transcribed spacer identification (ITSI) as a complementary-method in the diagnosis of fungal keratitis

Evaluation of the feasibility of applying internal transcribed spacer identification (ITSI) as a complementary-method in the diagnosis of fungal keratitis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023720
Enrollment
Unknown
Registered
2019-06-08
Start date
2019-06-04
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

Fungal keratitis

Interventions

Gold Standard:KOH smear, confocal microscopy, fungal culture
Index test:Internal&#32
Transcribed&#32
Spacer&#32
Identification&#32
(ITSI)

Sponsors

Qingdao Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 200 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with fungal keratitis by clinical diagnosis; 2. Patients excluded from other combined ocular surface diseases; 3. Patients fully understand the condition and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients coexisting with other ocular surface diseases; 2. Patients who are participating in other clinical trials; 3. Patients that researchers believe that other reasons are not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Positive rate of KOH smear ;Positive rate of in vivo confocal microscopy (IVCM);Positive rate of fungi culture;Positive rate of ITSI;SEN, SPE, ACC, AUC of ROC;—

Countries

China

Contacts

Public ContactYusen Huang

The State Key Laboratory Cultivation Base, Shandong Provincial Key Laboratory of Ophthalmology, Shandong Eye Institute and Qingdao eye hospital

huang_yusen@126.com+86 13791802251

Outcome results

None listed

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