Bioengineered corneal tissue for minimally invasive vision restoration in advanced keratoconus in two clinical cohorts.
Journal
Nature biotechnology
ISSN: 1546-1696
Titre abrégé: Nat Biotechnol
Pays: United States
ID NLM: 9604648
Informations de publication
Date de publication:
01 2023
01 2023
Historique:
received:
28
04
2021
accepted:
29
06
2022
pubmed:
12
8
2022
medline:
21
1
2023
entrez:
11
8
2022
Statut:
ppublish
Résumé
Visual impairment from corneal stromal disease affects millions worldwide. We describe a cell-free engineered corneal tissue, bioengineered porcine construct, double crosslinked (BPCDX) and a minimally invasive surgical method for its implantation. In a pilot feasibility study in India and Iran (clinicaltrials.gov no. NCT04653922 ), we implanted BPCDX in 20 advanced keratoconus subjects to reshape the native corneal stroma without removing existing tissue or using sutures. During 24 months of follow-up, no adverse event was observed. 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). 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. This work demonstrates restoration of vision using an approach that is potentially equally effective, safer, simpler and more broadly available than donor cornea transplantation.
Identifiants
pubmed: 35953672
doi: 10.1038/s41587-022-01408-w
pii: 10.1038/s41587-022-01408-w
pmc: PMC9849136
doi:
Banques de données
ClinicalTrials.gov
['NCT04653922']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
70-81Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2022. The Author(s).
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