Development of simple limbal epithelial transplantation for treatment of limbal stem cell deficiency in Thailand
- Conditions
- imbal stem cell deficiencylimbal stem cell deficiency (LSCD)limbal simple stem cell transplantation (SLET)
- Registration Number
- TCTR20170609001
- Lead Sponsor
- ational Science and Technology Development Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1. Patients with unilateral or bilateral limbal stem cell deficiency (LSCD) from chemical or thermal burns, chronic keratitis, multiple corneal surgeries, and prolonged use of eye drops
2. Patients with clinical signs of LSCD at least 180 degrees of the corneal circumference
3. Patients diagnosed with LSCD by impression cytology
1. Patients aged below 18 years
2. Patients with severe dry eye (Schirmer's test = 0 mm)
3. Patients with uncontrollable glaucoma
4. HIV-infected patients
5. Patients with hepatitis C virus infection
6. Patients with ongoing ocular infection
7. Patients with contraindications of ocular surgery or general anesthesia
8. Patients with pregnancy
9. Patients unable to follow-up
10. Patients with non-compliance, physically or mentally
Additional exclusion criteria for allo-SLET patients
1. Patients with contraindications of immunosuppressive agents or sterioids e.g. uncontrollable diabetes mellitus, ongoing systemic infection, hepatic failure, renal failure, etc.
2. Patients allergic to immunosuppressive agents or steroids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular surface status pre-op, post-op at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 mo signs of limbal deficiency, impression cytology, and in vivo confocal microscopy,Ocular surface status Three years signs of limbal deficiency, impression cytology, and in vivo confocal microscopy
- Secondary Outcome Measures
Name Time Method /A N/A N/A