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Cryopreservation of extracted corneal lenticules after small incision lenticule extraction for potential use in human subjects.

AbstractPURPOSE:
To describe the technique of cryopreservation of corneal lenticules extracted after small incision refractive lenticule extraction (ReLEx SMILE) and initial results of femtosecond laser intrastromal lenticular implantation for hyperopia.
METHODS:
Lenticules were collected from patients undergoing ReLEx SMILE for the correction of myopia and subjected to a tissue processing technique and cryopreservation. These lenticules were subsequently used to treat 8 hyperopic eyes and 1 aphakic eye. A femtosecond laser was used to create a pocket into each patient's cornea, followed by implantation of a cryopreserved lenticule. The patients were monitored through follow-up examinations for a mean 155.4 days (38-310 days).
RESULTS:
The mean interval from storage of lenticules to removal from liquid nitrogen was 96 days (range, 19-178 days). Mean spherical equivalent of hyperopic eyes treated was +4.50 ± 1.1 diopter (D). Mean keratometry and pachymetry changed from preoperative 43.9 D and 531.6 μm to 47.4 D and 605.2 μm, respectively, postoperatively. Mean residual spherical equivalent for hyperopic eyes was +0.6 D and +4.1 D for the aphakic eye. None of the eyes showed evidence of rejection or loss of best-corrected visual acuity at the end of the follow-up period.
CONCLUSIONS:
The cryopreservation technique seems to be a safe method of long-term storage of refractive lenticules extracted after ReLEx SMILE for use in allogeneic human subjects. It may potentially be a safe and effective alternative to excimer laser ablation for hyperopia because of the low risks of regression, haze, flap-related complications, postoperative dry eye, and higher-order aberrations.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: CTRI/2014/01/004331.
AuthorsSri Ganesh, Sheetal Brar, Pallavi A Rao
JournalCornea (Cornea) Vol. 33 Issue 12 Pg. 1355-62 (Dec 2014) ISSN: 1536-4798 [Electronic] United States
PMID25343698 (Publication Type: Journal Article)
Topics
  • Adult
  • Corneal Stroma
  • Corneal Surgery, Laser
  • Cryopreservation (methods)
  • Female
  • Humans
  • Hyperopia (surgery)
  • Male
  • Myopia (surgery)
  • Organ Preservation (methods)
  • Refraction, Ocular (physiology)
  • Time Factors
  • Tissue Transplantation
  • Visual Acuity (physiology)

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