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

Ganesh S, Brar S, Rao PA - Cornea (2014)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: *Department of Phaco and Refractive Surgery, Nethradhama SuperSpeciality Eye Hospital, Bangalore, India; and †Department of Reproductive Biology, Cryostemcell (K) Pvt. Ltd, Bangalore, India.

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.

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A, Serial digital clinical photographs (16×) of 32-year-old woman operated for +6.5 D hyperopia in the right eye with FILI. Photographs were taken on day 15 and 6 months after the operation. Distance from edge of the lenticule to limbus was measured at 3 points and verified at every visit to check for centering and any shift in position. B, Six-month postoperative anterior segment optical coherence tomography of an eye treated for +6.5 D hyperopia showing a clear and well-centered lenticule.
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Figure 2: A, Serial digital clinical photographs (16×) of 32-year-old woman operated for +6.5 D hyperopia in the right eye with FILI. Photographs were taken on day 15 and 6 months after the operation. Distance from edge of the lenticule to limbus was measured at 3 points and verified at every visit to check for centering and any shift in position. B, Six-month postoperative anterior segment optical coherence tomography of an eye treated for +6.5 D hyperopia showing a clear and well-centered lenticule.

Mentions: On day 1, in the first 2 consecutive eyes, the implanted lenticules had mild to moderate Descemet membrane folds that resolved spontaneously within 1 week. Subsequently, the treated eyes were prescribed hypertonic saline drops, which showed clear lenticules within 48 hours and until the last follow-up time point. The lenticules were stable and did not show any shift with time. Figure 2 shows serial clinical photographs and anterior segment optical coherence tomography of the eye treated with FILI at day 15 and at 6 months post-FILI showing clear lenticules with good centration.


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

Ganesh S, Brar S, Rao PA - Cornea (2014)

A, Serial digital clinical photographs (16×) of 32-year-old woman operated for +6.5 D hyperopia in the right eye with FILI. Photographs were taken on day 15 and 6 months after the operation. Distance from edge of the lenticule to limbus was measured at 3 points and verified at every visit to check for centering and any shift in position. B, Six-month postoperative anterior segment optical coherence tomography of an eye treated for +6.5 D hyperopia showing a clear and well-centered lenticule.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4218759&req=5

Figure 2: A, Serial digital clinical photographs (16×) of 32-year-old woman operated for +6.5 D hyperopia in the right eye with FILI. Photographs were taken on day 15 and 6 months after the operation. Distance from edge of the lenticule to limbus was measured at 3 points and verified at every visit to check for centering and any shift in position. B, Six-month postoperative anterior segment optical coherence tomography of an eye treated for +6.5 D hyperopia showing a clear and well-centered lenticule.
Mentions: On day 1, in the first 2 consecutive eyes, the implanted lenticules had mild to moderate Descemet membrane folds that resolved spontaneously within 1 week. Subsequently, the treated eyes were prescribed hypertonic saline drops, which showed clear lenticules within 48 hours and until the last follow-up time point. The lenticules were stable and did not show any shift with time. Figure 2 shows serial clinical photographs and anterior segment optical coherence tomography of the eye treated with FILI at day 15 and at 6 months post-FILI showing clear lenticules with good centration.

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: *Department of Phaco and Refractive Surgery, Nethradhama SuperSpeciality Eye Hospital, Bangalore, India; and †Department of Reproductive Biology, Cryostemcell (K) Pvt. Ltd, Bangalore, India.

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.

Show MeSH
Related in: MedlinePlus