NCT00348114

Brief Summary

To evaluate the effectiveness of autologous (tissue from fellow eye) transplantation of cultivated limbal epithelium on amniotic membrane to treat severe surface irregularity and scarring of the corneal surface.

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

July 4, 2006

Status Verified

January 1, 2002

First QC Date

July 3, 2006

Last Update Submit

July 3, 2006

Conditions

Ocular Surface Disease

Keywords

autologoustransplantation ex-vivo expanded limbal epitheliumlimbal deficiency

Outcome Measures

Primary Outcomes (2)

  • Snellen visual acuity

  • corneal epithelial integrity and stability

Secondary Outcomes (1)

  • extent of retarding recurrent neovascularisation

Interventions

Transplantation of cultivated limbal epitheliumPROCEDURE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral total limbal stem cell deficiency with normal fellow eye, or minimally damaged fellow eye (less than 1/3 limbus affected)

You may not qualify if:

  • systemic disease affecting both eyes such as Stevens-Johnson syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ti SE, Anderson D, Touhami A, Kim C, Tseng SC. Factors affecting outcome following transplantation of ex vivo expanded limbal epithelium on amniotic membrane for total limbal deficiency in rabbits. Invest Ophthalmol Vis Sci. 2002 Aug;43(8):2584-92.

    PMID: 12147589BACKGROUND

  • Tsai RJ, Li LM, Chen JK. Reconstruction of damaged corneas by transplantation of autologous limbal epithelial cells. N Engl J Med. 2000 Jul 13;343(2):86-93. doi: 10.1056/NEJM200007133430202.

    PMID: 10891515BACKGROUND

Study Officials

  • Seng-Ei Ti, FRCS(Ed)

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

  • Donald TH Tan, FRCS(G)

    Singapore Eye Research Institute and Singapore National Eye Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

May 1, 2002

Study Completion

May 1, 2006

Last Updated

July 4, 2006

Record last verified: 2002-01