3D Corneal Shape After Implantation of a Biosynthetic Corneal Stromal Substitute

Ong, Jeb Alden; Auvinet, Edouard; Forget, Karolyn J.; Lagali, Neil; Griffith, May; Meunier, Jean; Brunette, Isabelle

doi:10.1167/iovs.15-18271

Cited by 14 publications

(12 citation statements)

References 56 publications

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“…Notably, vision in the present study at 24 months was either equivalent (Iranian cohort) or improved (Indian cohort) relative to an earlier biosynthetic collagen-based material implanted by more invasive lamellar keratoplasty in ten Swedish subjects 27 . In that study, however, the mean long-term K max decrease was a non-significant 2.5 D, and subjects had a milder grade of initial keratoconus 47 with substantially less steep corneas and less advanced disease relative to the subjects in the present cohorts (Supplementary Table 3). Topical corticosteroids are typically applied for up to one year following DALK and PK 48,49 to prevent suture-induced inflammation and neovascularization, and additionally the techniques require multiple post-operative visits and corrective surgical procedures [50][51][52] for re-suturing, suture removal and to manage suture-related complications and post-operative astigmatism caused by suture-induced tissue deformation and donor-recipient tissue mismatch 20 .…”

Section: Discussionmentioning

confidence: 52%

Bioengineered corneal tissue for minimally invasive vision restoration in advanced keratoconus in two clinical cohorts

et al. 2022

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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.

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Section: Discussionmentioning

confidence: 52%

Bioengineered corneal tissue for minimally invasive vision restoration in advanced keratoconus in two clinical cohorts

et al. 2022

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“…Two topography patterns predominated (Ong et al, 2016): (1) A localized, central or paracentral prominence that tended to adopt a hexagonal contour matching the area delineated by the overlying mattress sutures, and (2) a superior crescent-shaped flattening presumably due to the pressure of the superior lid. The amount of flattening of the keratoconus varied between patients.…”

Section: Clinical Results Achieved With First In Man Recombinant Humamentioning

confidence: 99%

Alternatives to eye bank native tissue for corneal stromal replacement

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Vidal

et al. 2017

Progress in Retinal and Eye Research

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“…Four years after the grafting (37), patient CDVA was 20/54 on average and a gain of more than the 5 Snellen lines of vision on an eye chart. At four years, the biosynthetic corneas showed steeper surface curvatures and were more irregular than that of donor tissue showing increased astigmatism (38).…”

Section: Resultsmentioning

confidence: 97%

Corneal Stromal Regeneration: A Review of Human Clinical Studies in Keratoconus Treatment

et al. 2021

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The use of advanced therapies with stem cells to reconstruct the complex tissue of corneal stroma has gained interest in recent years. Besides, collagen-based scaffolds bioengineering has been offered as another alternative over the last decade. The outcomes of the first clinical experience with stem cells therapy on corneal stroma regeneration in patients with advanced keratoconus were recently reported. Patients were distributed into three experimental groups: Group 1 (G-1) patients underwent implantation of autologous adipose-derived adult stem cells (ADASCs) alone, Group 2 (G-2) received a 120 μm decellularized donor corneal stromal laminas, and Group 3 (G-3) received a 120 μm recellularized donor laminas with ADASCs. A follow up of 36 months of clinical data, and 12 months of confocal microscopy study was performed, the authors found significant clinical improvement in almost all studied mean values of primary and secondary outcomes. Corneal confocal microscopy demonstrated an increase in cell density in the host stroma, as well as in the implanted tissue. Using different approaches, allogenic small incision lenticule extraction (SMILE) implantation was applied in cases with advanced keratoconus. Some authors reported the implantation of SMILE intrastromal lenticules combined with accelerated collagen cross-linking. Others performed intrastromal implantation of negative meniscus-shaped corneal stroma lenticules. Others have compared the outcomes of penetrating keratoplasty (PKP) vs. small-incision Intralase femtosecond (IFS) intracorneal concave lenticule implantation (SFII). Femtosecond laser-assisted small incision sutureless intrasotromal lamellar keratoplasty (SILK) has been also investigated. The published evidence shows that the implantation of autologous ADASCs, decellularized or recellularized human corneal stroma, allogenic SMILE lenticules corneal inlay, and recombinant cross-linked collagen have shown initially to be potentially effective for the treatment of advanced keratoconus. In light of the present evidence available, it can be said that the era of corneal stromal regeneration therapy has been already started.

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3D Corneal Shape After Implantation of a Biosynthetic Corneal Stromal Substitute

Cited by 14 publications

References 56 publications

Bioengineered corneal tissue for minimally invasive vision restoration in advanced keratoconus in two clinical cohorts

Bioengineered corneal tissue for minimally invasive vision restoration in advanced keratoconus in two clinical cohorts

Alternatives to eye bank native tissue for corneal stromal replacement

Corneal Stromal Regeneration: A Review of Human Clinical Studies in Keratoconus Treatment

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