Antibiotic Resistance, Microbial, Keratitis, Ulcerative, Photothermal Therapy
Conditions
Keywords
Photothermal Therapy, Keratitis, Ulcerative, Antibiotic Resistance, Microbial
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.
Interventions
DRUGHollow 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.
DRUGVoriconazole eye drops
Voriconazole eye drops (1%) were administrated to infectious eye very frequently (once half an hour)
OTHERNormal saline
To be placebo, normal saline were administrated to infectious eye
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior segment photography | 1 month | corneal edema, keratohelcosis, hppopyon |
| confocal microscopy | 1 month | fungal hyphae in corneal surface |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactYue Qiao, PhD
Outcome results
None listed