Clinical Trial: Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease

Brief Summary: The aim of the study is to assess if transplantation of cultivated corneal epithelial stem cells could restore vision in patients with severe ocular surface disorder with a favourable safety profile that warrants further comparative study.

Detailed Summary:

Objectives:

Efficacy:

To determine the efficacy of cultivated corneal epithelial stem cells as a treatment for patients with severe ocular surface disorder.

The corneal limbal epithelial stem cell transplant (CLET) successful outcome will be measured by improvement of vision, maintenance of corneal re-epithelisation with absence of recurrence of surface disease and subjective improvement of symptoms.


Sponsor: Ministry of Health, Malaysia

Current Primary Outcome:

  • Improvement of vision at one week [ Time Frame: One week ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
  • Improvement of vision at one month [ Time Frame: One month ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
  • Improvement of vision at three month [ Time Frame: Three month ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
  • Improvement of vision at six month [ Time Frame: Six month ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
  • Improvement of vision at nine month [ Time Frame: Nine month ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
  • Improvement of vision at twelve month [ Time Frame: Twelve month ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Adverse events reporting, vital signs, and physical examinations.
      To evaluate the safety and tolerability of transplantation of limbal epithelial cells cultured on amniotic membrane for a follow-up period of one year in patients. Safety will be evaluated using adverse events reporting, vital signs, and physical examinations.
    • Maintenance of corneal re-epithelisation with absence of recurrence of surface disease
    • Subjective improvement of symptoms


    Original Secondary Outcome: Same as current

    Information By: Ministry of Health, Malaysia

    Dates:
    Date Received: April 22, 2010
    Date Started: August 2011
    Date Completion: September 2012
    Last Updated: July 7, 2011
    Last Verified: May 2010