In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.
There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus.
The amniotic membrane graft cultured with the human limbal stem cell transplantation is placed in the limbic and corneal surface and fixed with fibrin glue. The amniotic membrane is placed with the stroma in contact with the graft and it is sutured.
Instituto de Oftalmologia Conde de Valenciana
Mexico City, Mexico
Objective clinical evaluation
A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.
Time frame: 6 months
Objective clinical evaluation
A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.
Time frame: 12 months
Corneal cells morphology
Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology
Time frame: 6 months
Corneal cells morphology
Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology
Time frame: 12 months
Quality of life questionnaire
Modified National Eye Institute Visual Function Questionnaire 25 questionnaire
Time frame: 6 months
Quality of life questionnaire
Modified National Eye Institute Visual Function Questionnaire 25 questionnaire
Time frame: 12 months
Visual acuity
Visual acuity in the Logarithm of the Minimum Angle of Resolution scale
Time frame: 6 months
Visual acuity
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Visual acuity in the Logarithm of the Minimum Angle of Resolution scale
Time frame: 12 months