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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Keratitis, Ulcerative Antibiotic Resistance, Microbial Photothermal Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Nanogel photothermal therapy

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)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel was excited by NIR laser to release functional silver ions, copper ions and ROS.

Voriconazole eye drops

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

Group Type ACTIVE_COMPARATOR

Voriconazole eye drops

Intervention Type DRUG

Voriconazole eye drops (1%) were administrated to infectious eye very frequently (once half an hour)

Normal saline

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

To be placebo, normal saline were administrated to infectious eye

Interventions

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

Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel was excited by NIR laser to release functional silver ions, copper ions and ROS.

Intervention Type DRUG

Voriconazole eye drops

Voriconazole eye drops (1%) were administrated to infectious eye very frequently (once half an hour)

Intervention Type DRUG

Normal saline

To be placebo, normal saline were administrated to infectious eye

Intervention Type OTHER

Other Intervention Names

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Au-Ag-Cu2O nano-gel VRC NS

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No