Epithelial cell transfer for severe corneal disease
Phase 1
Completed
- Conditions
- imbal stem cells deficiencyLimbal stem cells deficiencyEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12607000211460
- Lead Sponsor
- Inflammatory Diseases Research Unit, School of Medical Sciences, University of NSW
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
* patients with limbal stem cell deficiency diseases* patients capable of giving written informed consent and complying with the study protocol.
Exclusion Criteria
* patients with corneal perforationpatients with autoimmune disease (e.g rheumatoid arthritis, MOoren's ulcer, lupus etc)*active bacterial, fungal, or amoebic ulcers*vitamin A deficiency* pregnant or lactating women* viral infections.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A stable and healthy corneal epithelium. Indicators of a healthy cornea may include healing of a corneal ulcer or inhibition of conjunctivilisation. [Ocular health will be monitored twice weekly with the contact lense left over the affected eye, then weekly over the next 4-weeks, monthly over the next 6-months, then 6-monthly over the next two years.]
- Secondary Outcome Measures
Name Time Method Corneal epithelial integrity and re-surfacing.[ Both parameters will be measured twice weekly for the first two weeks, weekly for the next 4-weeks, monthly for the next 6-months, then 6monthly for the following 2-3 years.]