Early clinical outcomes of keratoplasty using donor corneas preserved in sinasol (ZiSol) versus optisol-GS
摘要
To compare early postoperative outcomes of penetrating keratoplasty (PKP) and Descemet stripping automated endothelial keratoplasty (DSAEK) using donor corneas preserved in ZiSol (formerly Sinasol) versus Optisol-GS. Prospective, double-masked, randomized clinical trial. Ninety-seven eligible eyes undergoing PKP or DSAEK were randomized to receive corneas preserved in ZiSol or Optisol-GS at 4 °C. Preoperative assessments included uncorrected distance visual acuity (UDVA) and corneal edema grading. Postoperative visits at 1 week, 1, 3, and 6 months assessed UDVA, corrected distance visual acuity (CDVA), corneal edema grading, re-epithelialization, microbial keratitis, suture-related complications, and graft attachment (for DSAEK). The PKP cohort comprised 32 ZiSol and 20 Optisol-GS cases; the DSAEK cohort included 13 ZiSol and 23 Optisol-GS cases. At 6 months, mean CDVA was 0.52 ± 0.28 LogMAR (ZiSol) versus 0.41 ± 0.13 LogMAR (Optisol-GS) after PKP (P = 0.132) and 0.47 ± 0.26 versus 0.63 ± 0.40 LogMAR after DSAEK (P = 0.272). Final graft clarity was achieved in 93.3% (ZiSol) and 95.3% (Optisol-GS) of recipients. Complete re-epithelialization by day 7 occurred in 96.9% versus 100% of PKP cases (P > 0.999). Microbial keratitis occurred in 6.3% (ZiSol) and 0% (Optisol-GS) after PKP (P = 0.517). Complete graft attachment after DSAEK occurred in 100% (ZiSol) versus 87% (Optisol-GS) (P = 0.288). Early postoperative outcomes of PKP and DSAEK using ZiSol-preserved donor corneas were statistically comparable to those with Optisol-GS. ZiSol appears to be a safe, effective, and locally accessible alternative for mid-term hypothermic storage in resource-limited settings.