Limbal Stem-cell Deficiency Clinical Trial
Official title:
The Effects of Allogeneic Simple Limbal Epithelial Transplantation
NCT number | NCT04021134 |
Other study ID # | 201904118RINB |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 5, 2019 |
Est. completion date | July 1, 2025 |
To investigate the effect of allogeneic SLET and re-epithelialization after allogeneic SLET.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Ophthalmology, National Taiwan University Hospital, | Taipei | |
Taiwan | National Taiwan University Hospital | Taipei | Taiwan, Republic Of China |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Borroni D, Wowra B, Romano V, Boyadzhieva M, Ponzin D, Ferrari S, Ahmad S, Parekh M. Simple limbal epithelial transplantation: a review on current approach and future directions. Surv Ophthalmol. 2018 Nov - Dec;63(6):869-874. doi: 10.1016/j.survophthal.2018.05.003. Epub 2018 May 22. Review. — View Citation
Iyer G, Srinivasan B, Agarwal S, Tarigopula A. Outcome of allo simple limbal epithelial transplantation (alloSLET) in the early stage of ocular chemical injury. Br J Ophthalmol. 2017 Jun;101(6):828-833. doi: 10.1136/bjophthalmol-2016-309045. Epub 2016 Oct 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numbers of patients with clinical success | Clinical success is defined as a completely epithelized, avascular, stable corneal surface. Failure was defined as a recurrence of fibrovascular pannus encroaching on the central cornea, frequent epithelial breakdown or persistent epithelial defects. Focal recurrences of pannus not progressing to the central cornea were not considered as failures and were evaluated separately. | 6 months | |
Secondary | Best corrected visual acuity change | Best corrected visual acuity (BCVA) was measured with Snellen chart preoperatively and at 6 months after the operation. | 6 months |
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