Gold-silver-cuprous Oxide (Au-Ag-Cu2O) Composite Nanogel Combined With Photothermal Therapy in the Treatment of Severe Drug-resistant Microbial Keratitis
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Anterior segment photography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •After more than 2 weeks of active treatment with antibiotics, there was no effect
- •The researchers communicated with the subjects in detail, and the subjects cooperated well and they voluntarily participated and signed informed consent
排除标准
- •Allergic to the drug in this test.
- •Pregnant and lactating women.
- •The medical history suggests serious heart, lung, liver, kidney dysfunction.
- •Patients with other factors that would affect the results of this result.
- •No signed informed consent.
研究组 & 干预措施
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)
干预措施: Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel (Drug)
Voriconazole eye drops
Voliconazole eye drops (once in half an hour) were also used in the control group.
干预措施: Voriconazole eye drops (Drug)
Normal saline
Normal saline eye drops (once in half an hour) were also used in the control group.
干预措施: Normal saline (Other)
结局指标
主要结局
Anterior segment photography
时间窗: 1 month
corneal edema, keratohelcosis, hppopyon
confocal microscopy
时间窗: 1 month
fungal hyphae in corneal surface
次要结局
- eye pressure(1 month)
- visual acuity(1 month)