We developed cell-free implants, comprising carbodiimide crosslinked recombinant human collagen (RHC), to enable corneal regeneration by endogenous cell recruitment, to address the worldwide shortage of donor corneas. Patients were grafted with RHC implants. Over four years, the regenerated neo-corneas were stably integrated without rejection, without the long immunosuppression regime needed by donor cornea patients. There was no recruitment of inflammatory dendritic cells into the implant area, whereas, even with immunosuppression, donor cornea recipients showed dendritic cell migration into the central cornea and a rejection episode was observed. Regeneration as evidenced by continued nerve and stromal cell repopulation occurred over the four years to approximate the micro-architecture of healthy corneas. Histopathology of a regenerated, clear cornea from a regrafted patient showed normal corneal architecture. Donor human cornea grafted eyes had abnormally tortuous nerves and stromal cell death was found. Implanted patients had a 4-year average corrected visual acuity of 20/54 and gained more than 5 Snellen lines of vision on an eye chart. The visual acuity can be improved with more robust materials for better shape retention. Nevertheless, these RHC implants can achieve stable regeneration and therefore, represent a potentially safe alternative to donor organ transplantation.
With the advent of microinvasive glaucoma surgery (MIGS), the spectrum of modalities available to manage patients with this chronic and heterogeneous condition has broadened. Despite its novelty however, there has been a rapid evolution in the development of a multitude of devices, each targeting a structure along the aqueous drainage pathway. A growing body of evidence has demonstrated IOP and medication burden reduction, and a more favorable safety profile with MIGS procedures in contrast to traditional incisional surgeries. Among the array of MIGS, the Hydrus® Microstent (Ivantis, Inc., Irvine, CA) is a recent FDA approved device, designed to bypass the trabecular meshwork and provide a scaffold for Schlemm’s canal. The objective of this article is to review the Hydrus from conception to clinical use, and present data on its efficacy and safety to date. The available literature has shown promise, however inherent to all novel devices, only long-term monitoring will ensure sustained IOP control and an acceptable safety profile. Surgical advancements in glaucoma have revolutionized the field, and continued research and development will establish these approaches in clinical treatment algorithms.
These results indicate that in normal eyes, the anterior elevation, posterior elevation, and pachymetry of the right and left corneas show remarkable symmetry. This comprehensive analysis was achieved with the purpose of guiding the development of future biosynthetic corneal substitutes.
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