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Clinical study of the low-temperature plasma surgery system for the treatment of infectious keratitis

Clinical study of the low-temperature plasma surgery system for the treatment of infectious keratitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008830
Enrollment
Unknown
Registered
2016-07-12
Start date
2016-07-05
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infectious keratitis

Interventions

PLA:low-temperature plasma (PLA) surgery system treatment
Corneal scraping:Corneal scraping
Medical treatment control:Antifungus medical treatment

Sponsors

Eye and ENT Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >18 years old; 2. positive pathogeny examination (smear, culture positive for bacteria or fungus, or confocal microscopy positive for fungus or amoeba); 3. mild to moderate corneal ulcer (size = 5mm, depth = 50%, with dense stromal infiltration upto mid-stroma and without scleral involvement); 4. inform consent and agree to enroll in the study.

Exclusion criteria

Exclusion criteria: 1. severe corneal ulcer (size > 5mm, depth > 50%, with deep dense stromal infiltration or with scleral involvement; 2. corneal perforation, anterior chamber disappearance, or other conditions calling for surgery; 3. systemic diseases that could not endure the treatment.

Design outcomes

Primary

MeasureTime frame
Time to healing;

Secondary

MeasureTime frame
Best Corrected Visual Acuity (BCVA);Depth of ucler;Ulcer size;Depth of hypopyon;Length of treatment before presentation;Length of medical treatment before intervention;

Countries

China

Contacts

Public ContactXu Jianjiang

Eye and ENT Hospital, Fudan University

jianjiangxu@126.com+86 13816881607

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026