Hyper-CLâ?¢ lens to reduce treatment burden in Subjects with Bacterial Keratitis.
- Conditions
- Health Condition 1: H168- Other keratitis
- Registration Number
- CTRI/2022/08/045043
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
1.Subject is 18-86 years old
2.Subject with Bacterial keratitis in one eye only
3.Subject with Bacterial Keratitis infiltrate of at least 1.5 mm in diameter
4.Subjects with no prior antibiotic treatment or treatment up to 12 hours prior enrolment.
5.Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
1.Perforation
2.Subject with elevated bleb (glaucoma shunts)
3.Sign of inflammation in both eyes
4.Severe itching suggesting viral infection or allergy reaction
5.Subepithelial infiltrate suggesting viral infection
6.Dendrite like ulcer or suspecting of Herpes keratitis
7.Previous penetrating keratoplasty
8.Pregnancy
9.Any infiltration suggesting other than bacterial infection e.g., parasite, fungal.
10.Post refractive surgery
11.Corneal inlays
12.Subject with neuropathic corneas
13.Subjects with Chronic autoimmune diseases
14.Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.
15.Participation in another clinical study within the past 30 days
16.Patient requires different treatment regimen then determined by the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method