• Cornea/External Disease, Refractive Mgmt/Intervention

    This study evaluates the 1-year safety and efficacy of an adipose-derived adult stem cell (ADASc) implant, applied with or without sheets of decellularized donor human corneal stroma, in patients with advanced keratoconus.

    Study design

    The authors performed a prospective interventional non-randomized study of 14 consecutive patients with advanced keratoconus. Each underwent implantation with either 1) autologous ADASc, 2) decellularized 120-μm thick corneal stroma lamina from a donor or 3) donor lamina recellularized with 1x106 autologous ADASc with an additional  1x106 cells at the time of surgery. Autologous ADASc were obtained by elective liposuction. Implantation was performed into the corneal stroma through a femtosecond-assisted 9.5-mm diameter lamellar dissection under topical anesthesia.

    Outcomes

    Twelve months after implantation, the average corrected distance visual acuity improved by 0.231, 0.264 and 0.094 Snellen lines in groups 1, 2 and 3, respectively. In group 1, refractive parameters showed an overall stability, while sphere improved by 2.35D and 0.625D in groups 2 and 3, respectively. Anterior keratometry remained stable in group 1 and improved in groups 2 and 3 by an average of 2 D.  No adverse events or complications were noted.

    Limitations

    The study was limited by a small sample size with only 1 year of follow-up data.

    Clinical significance

    These findings introduce a new potential treatment for patients who have a high risk of perforation with deep anterior lamellar keratoplasty (DALK) or who may not fare well with a full-thickness transplant. The procedure appears to carry a low level of risk, though the study should be repeated in a larger population with longer follow-up times. It is noted, however, that vision did not improve enough to match the results of DALK or penetrating keratoplasty.