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

Primary Purpose

Keratitis, Ulcerative, Antibiotic Resistance, Microbial, Photothermal Therapy

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel
Voriconazole eye drops
Normal saline
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratitis, Ulcerative focused on measuring Photothermal Therapy, Keratitis, Ulcerative, Antibiotic Resistance, Microbial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Nanogel photothermal therapy

Voriconazole eye drops

Normal saline

Arm 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)

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

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

Outcomes

Primary Outcome Measures

Anterior segment photography
corneal edema, keratohelcosis, hppopyon
confocal microscopy
fungal hyphae in corneal surface

Secondary Outcome Measures

eye pressure
Measurement of contact tonometry with iCare TA01i tonometer after treatment (1 day, 1 week, 1 month)
visual acuity
Measurement of distance visual acuity with subjective refraction after treatment (1 week, 1 month)

Full Information

First Posted
February 9, 2022
Last Updated
February 24, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05268718
Brief Title
Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis
Official Title
Gold-silver-cuprous Oxide (Au-Ag-Cu2O) Composite Nanogel Combined With Photothermal Therapy in the Treatment of Severe Drug-resistant Microbial Keratitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis, Ulcerative, Antibiotic Resistance, Microbial, Photothermal Therapy
Keywords
Photothermal Therapy, Keratitis, Ulcerative, Antibiotic Resistance, Microbial

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nanogel photothermal therapy
Arm Type
Experimental
Arm 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)
Arm Title
Voriconazole eye drops
Arm Type
Active Comparator
Arm Description
Voliconazole eye drops (once in half an hour) were also used in the control group.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline eye drops (once in half an hour) were also used in the control group.
Intervention Type
Drug
Intervention Name(s)
Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel
Other Intervention Name(s)
Au-Ag-Cu2O nano-gel
Intervention Description
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
Intervention Name(s)
Voriconazole eye drops
Other Intervention Name(s)
VRC
Intervention Description
Voriconazole eye drops (1%) were administrated to infectious eye very frequently (once half an hour)
Intervention Type
Other
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NS
Intervention Description
To be placebo, normal saline were administrated to infectious eye
Primary Outcome Measure Information:
Title
Anterior segment photography
Description
corneal edema, keratohelcosis, hppopyon
Time Frame
1 month
Title
confocal microscopy
Description
fungal hyphae in corneal surface
Time Frame
1 month
Secondary Outcome Measure Information:
Title
eye pressure
Description
Measurement of contact tonometry with iCare TA01i tonometer after treatment (1 day, 1 week, 1 month)
Time Frame
1 month
Title
visual acuity
Description
Measurement of distance visual acuity with subjective refraction after treatment (1 week, 1 month)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Qiao, PhD
Phone
+8619818504850
Email
qiaosensei@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke Yao, MD
Organizational Affiliation
Second Affiliated Hospital of Zhejiang University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Qiao, PhD
Phone
+8619818504850
Email
qiaosensei@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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