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Assessment of the Safety and Efficacy of Portable Automatic Ocular Surface Imaging Device(PAOSID) in the Home-Based Management and Remote Monitoring of Fungal Keratitis

Assessment of the Safety and Efficacy ofPortable Automatic Ocular Surface Imaging Device(PAOSID) in the Home-Based Management and Remote Monitoring of Fungal Keratitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109042
Enrollment
Unknown
Registered
2025-09-10
Start date
2025-09-15
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Fungal keratitis

Interventions

outpatient group:Regular outpatient follow-up
PAOSID group:Taking photographs and uploading images using the Portable Automated Ocular Surface Imaging Device (PAOSID)

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years; 2.Patients with moderate fungal keratitis, defined as having a measurable maximum lesion diameter of fungal keratitis >=2 mm and <=6 mm, and involving no more than the anterior two-thirds of the corneal stroma (as measured by OCT); 3.The participant is able to operate the APP and the portable camera and can cooperate with PAOSID to produce clear images that fully expose the cornea; 4.Participants who meet all the requirements for informed consent. Before any study-related procedures are conducted, the participant and/or their legal representative must read the informed consent document and sign and date it; 5.Participants must have the capacity and willingness to comply with the study procedures.

Exclusion criteria

Exclusion criteria: 1.Concurrent intraocular infection; 2.Severe anterior chamber inflammation with risks of synechial pupillary block, corneal perforation, and intraocular involvement; 3.Patients whom the investigator deems to require corneal transplantation or conjunctival flap coverage surgery; 4.The merger involves other eye diseases including, but not limited to: patients with eyelid closure inadequacy, entropion, ectropion, and severe ocular trauma; as well as individuals with fungal keratitis in both eyes; 5.Individuals with a history of intraocular surgery or laser surgery within the past 3 months; 6.Patients with unstable intraocular pressure control or at risk of elevated intraocular pressure; 7.Patients with concurrent infections from other pathogens such as bacteria or viruses; 8.Patients with poor glycemic control; 9.Patients who have used or are currently using topical or systemic corticosteroids after the onset of the disease; 10.Pregnant and breastfeeding women; 11.Patients allergic to natamycin, voriconazole, or gatifloxacin;

Design outcomes

Primary

MeasureTime frame
The area of infiltrate reduction at Week 4 compared to baseline.;

Secondary

MeasureTime frame
complications;Epithelial defect area;Pinhole visual acuity(PHVA);

Countries

China

Contacts

Public ContactWei Chen

Eye Hospital, Wenzhou Medical University

chenweimd@wmu.edu.cn+86 577 88396800

Outcome results

None listed

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