The Effects of Autologous SLET

NCT04021875 | Unknown

• 1 other identifier: 201904117RINB
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Limbal Stem-cell Deficiency

Outcome Measures

Primary Outcomes (1)

• Numbers of patients with clinical success

  Clinical success was 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. Kaplan-Meier survival curves were constructed and survival probability calculated using the SPSS software for statistical computing. Focal recurrences of pannus not progressing to the central cornea were not considered as failures and were evaluated separately.

  6 months

Secondary Outcomes (1)

• Visual acuity change

  6 months

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with limbal stem cell deficiency

You may qualify if:

• Age 10-90 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:

• Symptoms improve spontaneously or under medication
• Someone who can not be examined regularly after the operation
• Someone with poor prognosis
• Severe lagophthalmos or trichiasis that has not been corrected
• Ocular infection

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, Republic of China, 10002, Taiwan

RECRUITING

Related Publications (3)

• Sangwan VS, Basu S, MacNeil S, Balasubramanian D. Simple limbal epithelial transplantation (SLET): a novel surgical technique for the treatment of unilateral limbal stem cell deficiency. Br J Ophthalmol. 2012 Jul;96(7):931-4. doi: 10.1136/bjophthalmol-2011-301164. Epub 2012 Feb 10.

  PMID: 22328817 RESULT

• Vazirani J, Ali MH, Sharma N, Gupta N, Mittal V, Atallah M, Amescua G, Chowdhury T, Abdala-Figuerola A, Ramirez-Miranda A, Navas A, Graue-Hernandez EO, Chodosh J. Autologous simple limbal epithelial transplantation for unilateral limbal stem cell deficiency: multicentre results. Br J Ophthalmol. 2016 Oct;100(10):1416-20. doi: 10.1136/bjophthalmol-2015-307348. Epub 2016 Jan 27.

  PMID: 26817481 RESULT

• 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: 29800578 RESULT

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Wei-Li Chen, phD

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Wei-Li Chen, phD

CONTACT

+886223123456; cwlntuh@gmail.com

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 16, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)