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

Zhejiang University

Status and phase: Enrolling; Early Phase 1

Conditions: Photothermal Therapy; Keratitis, Ulcerative; Antibiotic Resistance, Microbial

Treatments: Other: Normal saline; Drug: Voriconazole eye drops; Drug: Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel

Study type: Interventional

Funder types: Other

Identifiers

NCT05268718

2021-0635

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 3 patient groups, including a placebo group

Nanogel photothermal therapy

Experimental group

Description:

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)

Treatment:

Drug: Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel

Voriconazole eye drops

Active Comparator group

Description:

Voliconazole eye drops (once in half an hour) were also used in the control group.

Treatment:

Drug: Voriconazole eye drops

Normal saline

Placebo Comparator group

Description:

Normal saline eye drops (once in half an hour) were also used in the control group.

Treatment:

Other: Normal saline