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    Regenerative cell therapy, tissue engineering are future treatments

    While ALK, EK have evolved for corneal replacement, researchers seeking new directions

    There have been major changes in the way keratoplasty has been performed over the past 15 years.

    Data from the Singapore Corneal Transplant Study shows there have been improved outcomes in the lamellar surgical techniques compared to the full thickness penetrating keratoplasty (PK). However, different centers and different registries have reported different results.

    Data published in 2014 in Ophthalmologyshowed worse outcomes with lamellar surgery compared to penetrating keratoplasty. It is important to look at registry data, which is from multiple surgeons.

    A study, published last year in PLOSOne2, compared PK to anterior lamellar keratoplasty (ALK) and endothelial keratoplasty (EK), looking at graft failure outcomes. In all of the multiple studies, there was no statistical significance when looking at failure. This highlights the importance of good training programs to try to improve outcomes.

    With EK, there are two difficulties with the surgical procedure. One is donor preparation and the other is graft insertion. Upfront, there are good options for outsourcing the donor preparation to eye banks.

    How much damage?

    The problem with graft insertion is there is no way to know, at the time of surgery, how much damage is being done to the endothelium. That can only be assessed 1 to 3 months postoperatively through specular microscopy, or confocal microscopy once the baseline edema clears.

    Physicians at the Singapore National Eye Center have developed a calcein AM staining system, called CAM, which they use with an adapted Spectralis HRA confocal scanning laser ophthalmoscope (Heidelberg Engineering). This allows the surgeon to immediately look at the amount of damage on the whole graft being prepared for EK surgery.  Even as methods improve, this will not solve the worldwide problem with donor retrievals.

    A survey of 95% of the world’s transplant data shows that for every one cornea transplanted, there are 70 people needing corneal transplantation, and that out of about 284,000 corneas that are harvested per year, only 185,000 are used. Of the almost 100,000 not used, 30% are lost because of positive serology, but 60% was lost because of low endothelial cell count.

    The leading indications for endothelial surgery are Fuchs’ dystrophy, bullous keratopathy, and corneal regrafting. In the future, regenerative medicine may be the approach for Fuchs’. The approach to treating bullous keratopathy will include tissue engineering and cell therapy, and tissue engineering will be used for regrafting as well.

    The difference with Fuch's

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