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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane
Under usual care treatment
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
Improvement of vision at 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
Time frame: One week
Improvement of vision at 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
Time frame: One month
Improvement of vision at 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
Time frame: Three month
Improvement of vision at 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
Time frame: Six month
Improvement of vision at 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
Time frame: Nine month
Improvement of vision at 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 line
Time frame: Twelve month
Adverse events reporting, vital signs, and physical examinations.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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