Evaluating the effects of a new eye surgery for stem cell deficiency
The Effects of Autologous Simple Limbal Epithelial Transplantation.
National Taiwan University Hospital · NCT04021875
This study is testing a new eye surgery called SLET to see if it can improve vision and quality of life for people with limbal stem cell deficiency.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 90 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Taipei, Taiwan, Republic Of China) |
| Trial ID | NCT04021875 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the therapeutic effects of autologous simple limbal epithelial transplantation (SLET) in patients suffering from limbal stem cell deficiency (LSCD). The study will monitor changes in visual acuity and quality of life before and after the surgical procedure. SLET is a novel technique that offers a potential alternative to cultivated limbal epithelial transplantation, especially in regions lacking the resources for more complex procedures. The study will include patients aged 10 to 90 years with significant LSCD symptoms lasting at least six months.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 10-90 with grade 2 or higher limbal stem cell deficiency causing recurrent corneal erosion and neovascularization.
Not a fit: Patients whose symptoms improve spontaneously or with medication, or those with severe ocular conditions, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve vision and quality of life for patients with limbal stem cell deficiency.
How similar studies have performed: While SLET is a relatively new technique, it has shown promise in preliminary evaluations, but long-term effectiveness compared to established methods like CLET remains to be fully determined.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 10-90 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. Symptoms improve spontaneously or under medication 2. Someone who can not be examined regularly after the operation 3. Someone with 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
- National Taiwan University Hospital — Taipei, Taiwan, Republic Of China, 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