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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanogel photothermal therapy | Experimental | 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) |
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| Voriconazole eye drops | Active Comparator | Voliconazole eye drops (once in half an hour) were also used in the control group. |
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| Normal saline | Placebo Comparator | Normal saline eye drops (once in half an hour) were also used in the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior segment photography | corneal edema, keratohelcosis, hppopyon | 1 month |
| confocal microscopy | fungal hyphae in corneal surface | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| eye pressure | Measurement of contact tonometry with iCare TA01i tonometer after treatment (1 day, 1 week, 1 month) | 1 month |
| visual acuity | Measurement of distance visual acuity with subjective refraction after treatment (1 week, 1 month) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Qiao, PhD | Contact | +8619818504850 | qiaosensei@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ke Yao, MD | Second Affiliated Hospital of Zhejiang University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Voriconazole eye drops | Drug | Voriconazole eye drops (1%) were administrated to infectious eye very frequently (once half an hour) |
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| Normal saline | Other | To be placebo, normal saline were administrated to infectious eye |
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| 1 month |
| ID | Term |
|---|---|
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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