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The access problem is complex, involving economic, cultural, technological, political and ethical barriers 2, 4. Over half of the world’s population does not have access to corneal transplantation owing to a lack of infrastructure for tissue donation, harvesting, testing and eye banking in LMICs 1, 3. With an incidence of over 1 million new cases of corneal blindness annually 5, the severe shortage of donor corneas presents an unequal burden of blindness heavily skewed towards low- and middle-income countries (LMICs) in Asia, Africa and the Middle East 2, 3. Although corneal blindness can be treatable by transplantation, an estimated 12.7 million people await a donor cornea, with one cornea available for every 70 needed 3. Loss of corneal transparency and poor refractive function are among the leading causes of blindness globally 1, 2, 3, 4. This work demonstrates restoration of vision using an approach that is potentially equally effective, safer, simpler and more broadly available than donor cornea transplantation. Fourteen of 14 initially blind subjects had a final mean best-corrected vision (spectacle or contact lens) of 20/36 and restored tolerance to contact lens wear. We document improvements in corneal thickness (mean increase of 209 ± 18 µm in India, 285 ± 99 µm in Iran), maximum keratometry (mean decrease of 13.9 ± 7.9 D in India and 11.2 ± 8.9 D in Iran) and visual acuity (to a mean contact-lens-corrected acuity of 20/26 in India and spectacle-corrected acuity of 20/58 in Iran). During 24 months of follow-up, no adverse event was observed. NCT04653922), we implanted BPCDX in 20 advanced keratoconus subjects to reshape the native corneal stroma without removing existing tissue or using sutures.
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In a pilot feasibility study in India and Iran ( no. We describe a cell-free engineered corneal tissue, bioengineered porcine construct, double crosslinked (BPCDX) and a minimally invasive surgical method for its implantation. Visual impairment from corneal stromal disease affects millions worldwide.
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