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    Frozen, fresh corneal donor carriers yield similar clinical outcomes

    Use of frozen tissue may increase availability of fresh tissue for other procedures while increasing accessibility of KPro surgery

     

    Results

    A total of 37 eyes were enrolled in the 24-month study, and one was lost to follow-up, resulting in a retention rate of 97%. Of these, 15 patients (mean age, 59 years; median visual acuity, counting fingers) received fresh corneal tissue, and 11 patients (mean age, 58 years; median visual acuity hand motions) received frozen tissue.

    Twenty-six patients were enrolled in the extension phase and none were lost to follow-up. No significant differences were seen in the baseline patient demographics; diagnostic category, (especially regarding patients with autoimmune disorders or chemical burns who are known to have worse prognoses in addition to all other indications), or past ocular history between the carrier graft groups.

    This was true among all patients followed for 24 months and those in the extension phase, according to Dr. Muzychuk.

    All procedures were uneventful. The total surgical times in the fresh and frozen groups did not differ significantly (51 and 56 minutes, respectively; p = 0.14). As expected, tissue preservation time differed significantly between the groups, on average 8.5 days for fresh tissue and 80.6 days for frozen tissue, respectively (p < 0.001).

    At 24 months postoperatively, the retention rate of the device was 100%. At 60 months, the retention rate was 97%. When broken down by tissue type, the fresh tissue group had a 100% retention rate, and the frozen tissue group had a 91% (n = 10/11) retention rate, a difference that did not reach significance (p = 1.00). One device was replaced at 51 months after implantation due to a carrier graft melt.

    The visual rehabilitation in the fresh and frozen groups was similar at 24 months postoperatively, after which time the visual acuity levels in both groups decreased.

    At the 60-month evaluation, the median corrected distance visual acuity (CDVA) improved to 20/150 compared with the baseline of counting fingers in the group that received fresh tissue. In the group that received frozen tissue, the median CDVA improved to 20/400 from hand motions at baseline. There were no significant differences in the rates of complications, particularly uveitis or corneal melting.

    “There were no statistically significant differences in the rates of complications such as retroprosthetic membrane, corneal melt or tissue necrosis, uveitis, glaucoma, or posterior segment complications between carrier graft groups at 24 or 60 months,” Dr. Muzychuk said.

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