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Clinical Trials/CTRI/2014/10/005114
CTRI/2014/10/005114
Suspended
Phase 1

A Clinical Trial to evaluate the safety and effectiveness of the RHCIII-MPC biosynthetic cornea in patients requiring deep anterior lamerllar keratoplasty

Dr May Griffith0 sites0 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr May Griffith
Status
Suspended
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

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
Dr May Griffith

Eligibility Criteria

Inclusion Criteria

  • •1\. Subjects must sign and be given a copy of the written Informed Consent form.
  • •2\. Subjects with CDVA 20/200 or worse as a result of corneal scar due to injury or infection in the operative eye or from progressive keratoconus or Dystrophies or any other causes requiring DALK.
  • •3\. Subjects must be\>\=18 and \<\= 60 years of age at the time of subject eligibility visit.
  • •4\. Subjects must be willing and able to return for scheduled follow\-up examinations for 12 months after surgery.

Exclusion Criteria

  • •1\.Subjects with severe or life\-threatening systemic disease.
  • •2\.Subjects with uncontrolled hypertension.
  • •3\. Subjects with autoimmune disease.
  • •4\. Subjects with uncontrolled diabetes or insulin\-dependent diabetes.
  • •5\. Subjects with an ocular infection.
  • •6\. Subjects with any anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis, iritis, corneal dystrophy, pseudoexfoliation, etc. in the operative eye.
  • •7\. Subjects with glaucoma in either eye.
  • •8\.Subjects with previous retinal detachment or retinal pathology in the operative eye.
  • •9\.Subjects with congenital bilateral cataracts.
  • •10\.Subjects with marked microphthalmos or aniridia in either eye.

Outcomes

Primary Outcomes

Not specified

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