Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis

Early Phase 1

• Conditions: Keratitis, Ulcerative; Photothermal Therapy; Antibiotic Resistance, Microbial
• Interventions: Drug: Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel; Other: Normal saline; Drug: Voriconazole eye drops

• Registration Number: NCT05268718
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08-01
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Study First Posted: 2022-03-07
• Last Update Posted: 2022-03-07
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. The monocular cases of severe infectious keratitis admitted to our center were diagnosed as fungal keratitis according to their medical history, physical signs and surface secretions smear examination of corneal ulcer lesions (severe was defined as subjects with visual acuity < 0.15, deep stromal infiltration or involvement diameter >2mm, with extensive infiltration around or with extensive suppuration)
2. After more than 2 weeks of active treatment with antibiotics, there was no effect
3. The researchers communicated with the subjects in detail, and the subjects cooperated well and they voluntarily participated and signed informed consent

Exclusion Criteria

1. Allergic to the drug in this test.
2. Pregnant and lactating women.
3. The medical history suggests serious heart, lung, liver, kidney dysfunction.
4. Patients with other factors that would affect the results of this result.
5. No signed informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanogel photothermal therapy	Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel	After the subjects were enrolled in the study, the eyes were coated with Au-Ag-Cu2O nano-gel once (the concentration was 26.4μg/mL, the dosage was suitable to cover the ulcer surface evenly, and the dosage was recorded). Combined with mdl-n-808-10w near-infrared laser (China changchun new industry photoelectric technology) combined with photothermal therapy (laser wavelength 808 nm, power 1.5W/cm2, temperature controlled at 40℃, lasting 10min)
Normal saline	Normal saline	Normal saline eye drops (once in half an hour) were also used in the control group.
Voriconazole eye drops	Voriconazole eye drops	Voliconazole eye drops (once in half an hour) were also used in the control group.

Primary Outcome Measures

Name	Time	Method
Anterior segment photography	1 month	corneal edema, keratohelcosis, hppopyon
confocal microscopy	1 month	fungal hyphae in corneal surface

Secondary Outcome Measures

Name	Time	Method
eye pressure	1 month	Measurement of contact tonometry with iCare TA01i tonometer after treatment (1 day, 1 week, 1 month)
visual acuity	1 month	Measurement of distance visual acuity with subjective refraction after treatment (1 week, 1 month)

Trial Locations

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China