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
- Adverse events reporting, vital signs, and physical examinations.