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Clinical Trials/CTRI/2019/07/020024
CTRI/2019/07/020024
Recruiting
Phase 1

Prospective Investigator Initiated Study to Evaluate the Biocompatibility and Indicative effectiveness of EndoArt in Subjects Having Corneal Edema with No Visual Potential - Not Applicable

Eye Yon Medical Ltd0 sites0 target enrollmentTBD

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: H171- Central corneal opacityHealth Condition 2: null- Corneal Edema with No Visual Potential
Sponsor
Eye Yon Medical Ltd
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Eye Yon Medical Ltd

Eligibility Criteria

Inclusion Criteria

  • 1\. Male Female Subject is over 50 years old
  • 2\. No Visual Potential
  • 3\. Clinical Corneal Edema
  • 4\. Corneal thickness \>650 μm
  • 5\. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study\-specific tests or procedures are performed.
  • 6\. Pseudophakic subject (anterior or posterior) with stable IOL.

Exclusion Criteria

  • 1\. History of ocular Herpes keratitis
  • 2\. Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
  • 3\. Irregular posterior cornea (e.g. post PKP)
  • 4\. Active infection of the cornea
  • 5\. Band keratopathy and/or limbal stem cell deficiency.
  • 6\. Moderate to severe dry eye
  • 7\. Subject with phthisis or phthisis suspect
  • 8\. Very low ocular pressure \<\=6 mmHg or higher than 25 mmHg.
  • 9\. Aphakia or subluxated lens or pseudophacodonesis
  • 10\. Subject with glaucoma shunt (e.g. Ahmend valve)

Outcomes

Primary Outcomes

Not specified

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