The Effects of Autologous SLET

National Taiwan University

Status: Enrolling

Conditions: Limbal Stem-cell Deficiency

Study type: Observational

Funder types: Other

Identifiers

NCT04021875

201904117RINB

Details and patient eligibility

About

This study aims to prospectively evaluate the therapeutic effects of autologous simple limbal epithelial transplantation for patients with limbal stem cell deficiency. The change of visual acuity, quality of life and so on will be monitored before and after surgery.

Full description

Human corneal epithelial cells are stratified squamous cells that cover the corneal surface. These cells are regenerated from cells known as limbal stem cells (LSCs) that grow continuously and proliferate from the limbus. Failure or damage at the limbal zone can occur from hereditary or acquired causes such as ocular burns, trauma, or diseases such as Stevens- Johnson syndrome, leading to limbal stem cell deficiency (LSCD). The treatment of LSCD includes transplantation of healthy limbal tissue or cultured limbal epithelial cells. In the last two decades, cultivated limbal epithelial transplantation (CLET) has been a widely used technique. In 2012, Sangwan and coworkers proposed a novel technique that they named simple limbal epithelial transplantation (SLET) for the treatment of unilateral LSCD1. SLET could have benefits for those centers that do not have the ability to perform cultivated limbal epithelial transplantation (CLET) preparation and could be especially useful for those countries that cannot afford a GMP center. Therefore, SLET is quickly gaining popularity in countries like India. As it is a relatively new technique, its long-term clinical effectiveness (similar to what is observed in CLET) must be noted before determining its actual benefits.Our study aims to prospectively evaluate the therapeutic effects of autologous simple limbal epithelial transplantation for patients with limbal stem cell deficiency. The change of visual acuity, quality of life and so on will be monitored before and after surgery. In this study, the effects of autologous simple limbal epithelial transplantation will be investigated.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 90 years old

Volunteers: No Healthy Volunteers

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