The purpose of this clinical study is to undertake a pilot safety and efficacy study of a synthetic biodegradable membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure
This study will involve the used of a synthetic biodegradable Poly Lactide-co-Glycolic Acid (PLGA) biodegradable, synthetic carrier membrane (PLGA) membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure. This has the potential to simplify the current procedure and make it safer and accessible to more surgeons and eventually benefit more patients. The use of PLGA membrane, in place of hAM for limbal transplants, is a novel technique and has a lot of promise and potential, which will potentially benefit patients at large and significantly bring down costs for the limbal transplants while reducing the disease transmission risks of using human donor tissue.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Poly-Lactic-co-Glycolic Acid (50:50) biodegradable, synthetic scaffold
LV Prasad Eye Institute
Hyderabad, Andhra Pradesh, India
Corneal Edema using Pachymetry
At Baseline and at Month 12
Time frame: 12 months
Intraocular Pressure by Standard Applanation Tonometry
At Baseline and at Month 12
Time frame: 12 months
Ocular Pain
Magnitude of pain will assessed as patient reported outcome using Visual Analogue Scale (VAS) in a scale of 1 to 10 (Wong-Baker Faces Pain Rating Scale)
Time frame: 12 months
Schirmer's test (5 minute) without anesthesia
Time frame: 12 months
Clinical Laboratory Adverse Events
Time frame: 12 months
Vital Signs
Time frame: 12 months
Regeneration of Stable Ocular Surface measured by Slit lamp Biomicroscopy Examination and Slit Lamp Photography
Time frame: 12 months
Best Corrected Visual Acuity by Snellen Chart
Time frame: 12 months
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