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Clinical Trials/CTRI/2023/05/052622
CTRI/2023/05/052622
Not Yet Recruiting
N/A

Phase I Clinical trial study to explore the feasibility and evaluate the clinical outcomes and safety of keratoplasty using bioengineered decellularized cross-linked human corneal graft in comparison to fresh human corneas: A novel therapeutic approach to combat corneal blindness in India.

All India Institute of Medical Sciences0 sites0 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
All India Institute of Medical Sciences
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

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

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.Age aged 18 years of age or above
  • 2\.Unilateral/ bilateral infectious keratitis or corneal opacity, satisfying the following criteria:
  • \[The patients undergoing emergency partial\-thickness keratoplasty for corneal infections (severe corneal ulcers or melts, with depth \<80% of corneal thickness and size \< 7mm) or corneal opacities (with depth of opacities upto 400 µm)]
  • 3\. Willing to participate and follow\-up for at least 6 months
  • 4\.Patient who able to give consent for the intervention. In cases where the patient is not able to give consent, then Legal Acceptable Representative (LAR) will do the same on behalf of patients.

Exclusion Criteria

  • b) Exclusion Criteria:
  • 1\.Those with corneal thickness \<450 µm
  • 2\.Those with limbus\-to\-limbus extent of corneal infection.
  • 3\.Patients with untreated concurrent ocular conditions, such as adnexal problems, infections, retinal pathology and glaucoma

Outcomes

Primary Outcomes

Not specified

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