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

Abstract

PURPOSE:

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.

• Authors: Sri Ganesh, Sheetal Brar, Pallavi A Rao
• Journal: Cornea (Cornea) Vol. 33 Issue 12 Pg. 1355-62 (Dec 2014) ISSN: 1536-4798 [Electronic] United States
• PMID: 25343698 (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)