Investigating the effects of allogeneic simple limbal epithelial transplantation
The Effects of Allogeneic Simple Limbal Epithelial Transplantation
National Taiwan University Hospital · NCT04021134
This study is testing if a new eye surgery using tissue from the other eye can help people with limbal stem-cell deficiency see better and keep their cornea healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 90 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 2 sites (Taipei, Taiwan, Republic Of China and 1 other locations) |
| Trial ID | NCT04021134 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of allogeneic simple limbal epithelial transplantation (SLET) on patients with limbal stem-cell deficiency. The approach involves using small pieces of limbus from the contralateral eye to promote re-epithelialization and restore corneal surface stability. The study will track outcomes such as visual acuity and the maintenance of a healthy corneal surface over a follow-up period of approximately 9 months. The findings will contribute to understanding the efficacy of SLET in treating this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 10 to 90 years with grade 2 or worse limbal stem cell deficiency that has not improved with medication.
Not a fit: Patients whose symptoms improve spontaneously or with medication, or those with severe ocular conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve vision and quality of life for patients suffering from limbal stem-cell deficiency.
How similar studies have performed: Previous studies on autologous SLET have shown promising results, indicating that allogeneic approaches may also be effective, although they are less commonly reported.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 10 to 90 years old 2. The lesion eye has at least grade 2 limbal stem cell deficiency 3. The lesion eye has limbal stem cell deficiency causing recurrent corneal erosion and neovascularization ingrowth 4. The symptoms last for at least 6 months and do not improve with medication Exclusion Criteria: 1. The symptoms improve spontaneously or with medication 2. Someone who can not be examined regularly after the operation 3. Poor prognosis 4. Severe lagophthalmos or trichiasis that has not been corrected 5. Ocular infection
Where this trial is running
Taipei, Taiwan, Republic Of China and 1 other locations
- National Taiwan University Hospital — Taipei, Taiwan, Republic Of China, Taiwan (RECRUITING)
- Department of Ophthalmology, National Taiwan University Hospital, — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Wei-Li Chen, phD
- Email: cwlntuh@gmail.com
- Phone: +886223123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Limbal Stem-cell Deficiency