The Effects of Allogeneic SLET
The Effects of Allogeneic Simple Limbal Epithelial Transplantation
1 other identifier
observational
30
1 country
2
Brief Summary
To investigate the effect of allogeneic SLET and re-epithelialization after allogeneic SLET.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2019
CompletedStudy Start
First participant enrolled
July 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJuly 18, 2019
June 1, 2019
12 months
July 3, 2019
July 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Best corrected visual acuity change
6 months
Eligibility Criteria
Patients with limbal stem cell deficiency
You may qualify if:
- Age between 10 to 90 years old
- The lesion eye has at least grade 2 limbal stem cell deficiency
- The lesion eye has limbal stem cell deficiency causing recurrent corneal erosion and neovascularization ingrowth
- The symptoms last for at least 6 months and do not improve with medication
You may not qualify if:
- The symptoms improve spontaneously or with medication
- Someone who can not be examined regularly after the operation
- Poor prognosis
- Severe lagophthalmos or trichiasis that has not been corrected
- Ocular infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Taiwan University Hospital
Taipei, Taiwan, Republic of China, 10002, Taiwan
Department of Ophthalmology, National Taiwan University Hospital,
Taipei, 100, Taiwan
Related Publications (2)
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.
PMID: 29800578BACKGROUNDIyer 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.
PMID: 28407620BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wei-Li Chen, phD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2019
First Posted
July 16, 2019
Study Start
July 5, 2019
Primary Completion
July 1, 2020
Study Completion
July 1, 2025
Last Updated
July 18, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share
No IPD sharing in this study