Limbal Stem Cell Deficiency
Conditions
Keywords
limbal stem cell deficiency
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.
Detailed description
Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is essential for normal vision. Defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). The donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under either local or general anesthesia.
Interventions
PROCEDURECultured limbal stem cells Transplantation
Transplantation of cultivated limbal epithelium on amniotic membrane
Sponsors
Small Business Developing Center
Labafi Nejad Eye Research Center
Royan Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization * Presence of Goblet cells on the cornea * Minimum tear was about 5 mm * Minimum duration of deficiency was 3 years * Vision was Light Perception
Exclusion criteria
* Systemic disease affecting both eyes such as Stevens-Johnson syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Snellen visual acuity | 6 months |
| corneal epithelial integrity and stability | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Impression cytology | 12 months |
| Extent of retarding recurrent neovascularisation | 12 months |
Countries
Iran
Outcome results
None listed