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PURPOSE: To evaluate the efficacy and safety of Bio-Hyalur LVD compared to Viscoat® ophthalmic viscosurgical device (OVD) in patients undergoing routine cataract surgery. SETTING: Two tertiary eye care hospitals in Italy. DESIGN: Prospective randomized clinical trial. METHODS: This study compared the outcomes of Bio-Hyalur LVD versus Viscoat® ophthalmic viscosurgical device in patients undergoing standard cataract surgery with phacoemulsification and intraocular lens implantation from January 2021 to April 2022. The primary outcome was mean change in IOP at 6 hours. Secondary outcomes included 1-, 7-, 30- and 90-day mean intraocular pressure (IOP), 7-, 30- and 90-day best corrected visual acuity, endothelial cell density (ECD), change in central corneal thickness (CCT) and complications including intraocular inflammation. RESULTS: A total of 84 eyes of 84 patients (n = 41 in the Bio-Hyalur LVD group and n = 43 in the Viscoat group) were screened, enrolled, randomized, and included in the analysis. Mean change in IOP was significantly higher in the Viscoat group than in the Bio-Hyalur LVD group 6 hours (p = 0.034), 7 days (p < 0.001), 30 days (p < 0.001) and 90 days (p = 0.003) postoperatively. Mean change in UDVA and CDVA was significantly higher in the Bio-Hyalur LVD group 30 and 90 after surgery. No significant differences in ECD, CCT and complication rates were observed between groups at any time point. CONCLUSION: Bio-Hyalur LVD OVD is safe and effective for use in patients undergoing routine cataract surgery. Bio-Hyalur LVD OVD did not confer a higher risk of postoperative increase in IOP.
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PURPOSE: To compare the outcomes of deep anterior lamellar keratoplasty (DALK) using dehydrated versus standard organ culture-stored donor corneas for eyes with keratoconus. DESIGN: Prospective, randomized, single-center trial conducted in Italy. PARTICIPANTS: Adult patients (age ≥ 18 years) with keratoconus scheduled for elective DALK. METHODS: Patients undergoing successful type 1 bubble pneumatic dissection using a standard DALK technique were randomized during surgery to receive either dehydrated (n = 30) or standard organ culture-stored (n = 30) donor corneas. MAIN OUTCOME MEASURES: The primary study outcome was best spectacle-corrected visual acuity (BSCVA) 12 months after surgery. Secondary outcomes were refractive astigmatism (RA), endothelial cell density (ECD), and complication rates. RESULTS: Postoperative BSCVA did not significantly differ between groups at both time points: mean difference at 6 months was 0.030 logarithm of the minimum angle of resolution (logMAR; 95% confidence interval [CI], -0.53 to 0.10 logMAR; P = 0.471) and at 12 months was -0.013 logMAR (95% CI, -0.10 to 0.08 logMAR; P = 0.764). No significant differences between groups were observed in terms of postoperative RA and ECD at all time points. In the first 3 days after DALK, an epithelial defect was present in 10 patients (33%) in the organ culture cornea group and in 29 patients (97%) in the dehydrated cornea group. Complete re-epithelialization was achieved by day 7 in all patients (100%) in both groups. CONCLUSIONS: The study provides evidence that the use of dehydrated corneas is noninferior to the use of standard organ culture donor corneas for DALK. Corneal tissue dehydration represents a viable solution that can allow long-term cornea preservation and avoid wastage of unused corneas. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.