CTRI/2015/08/006147
Completed
Phase 1
A proof of concept study to evaluate the clinical safety and efficacy of a Poly Lactide-co-Glycolic Acid (PLGA) biodegradable, synthetic carrier membrane, used to regenerate epithelium using autologous limbal tissue as a single step procedure in patients having total unilateral limbal stem cell deficiency (LSCD). - LVPEI-2012-11
Wellcome Trust for Affordable Healthcare India R D0 sites5 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Wellcome Trust for Affordable Healthcare India R D
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female participants who are \>\=18 years of age.
- •2\.Patients having a confirmed diagnosis of total LSCD as confirmed by any one or all of the following:
- •a.In\-growth of conjunctival epithelium over the cornea (conjunctivalization),
- •b.360o absence of limbal Palisades of Vogt,
- •c.A fine stippled appearance on fluorescein staining,
- •d.Persistent or recurrent corneal epithelial defects
- •e.Superficial vascularization,
- •f.Dull and irregular corneal epithelium.
- •3\.Participants having unilateral limbal stem cell deficiency due to chemical injury
- •4\.No prior history of limbal transplantation
Exclusion Criteria
- •1\.Bilateral LSCD
- •2\.LSCD due to autoimmune disorders and partial LSCD
- •3\.Having other ongoing ocular pathologies and acute ocular inflammation
- •4\.Previous neoplastic/cancer disease
- •5\.Severe dry eyes confirmed by Schirmerâ??s test
- •6\.Acute systemic infections
- •7\.Prior history of limbal transplantation surgery or multiple surgeries in the limbal region
- •8\.Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patientâ??s participation in the study or evaluation of the study results.
- •9\. Any uncontrolled, inter\-current illness that in the opinion of the Investigator may interfere with study evaluation.
- •10\.Participants with uncontrolled diabetes will be excluded from the study
Outcomes
Primary Outcomes
Not specified
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