Precise-Bio Vision Endothelial Keratoplasty For Endothelial Decompensation
Published 2025
- 43rd Congress of the ESCRS
Reference: FP07.15
| Type: Free paper
| DOI:
10.82333/keye-8t18
Authors:
Wessam Salem* 1
, Mohamed Hosny 2
1Ophthalmology,New Giza University,Cairo,Egypt, 2Ophthalmology,Cairo university,Cairo,Egypt
Purpose
This study aimed to evaluate the outcomes of Precise-Bio Vision Endothelial Keratoplasty (PVEK), a bioengineered corneal endothelial implant, in a rabbit model. PVEK consists of a collagen-based scaffold integrated with high-density, 3D-printed, donor-expanded human endothelial cells.
Setting
New Zealand White rabbits. First in Human Scheduled Q3 2025.
Methods
64 New Zealand White rabbits underwent an 8.25 mm descemetorhexis and were randomized into three groups: PVEK (implantation of a PVEK implant), Scaffold-only (implantation of a collagen-based scaffold), and Sham (descemetorhexis only). Both PVEK and Scaffold-only groups utilized C3F8 for endotamponade. Primary outcome measures included corneal cloudiness (graded 0-4) and central corneal thickness (CCT) measured by optical coherence tomography at one, three, and six months post-procedure. Secondary outcomes encompassed endothelial cell counts and temporal changes in corneal thickness.
Results
At six months, the PVEK group demonstrated significantly superior outcomes compared to other groups. Mean central corneal thickness in the PVEK group (391 ± 181 μm) was significantly lower than both the Scaffold-only (646 ± 297 μm, p=0.01) and Sham groups (757 ± 153 μm, p<0.001). At 6 months there was no significant difference in CCT when compared to baseline in the PVEK group only (paired t-test p=0.4), whereas the scaffold-only and sham groups demonstrated significantly thicker CCT compared to baseline (paired t-test; P<0.005 & P<0.0001 respectively). Moreover, PVEK implants showed high postoperative cell density, with endothelial cell counts of 2110 ± 171, 1894 ± 181 and 1793 ± 160 cells/mm² at 1, 3 and 6 months postoperatively.
Conclusions
This randomized study demonstrates that PVEK results in clear and compact corneas with high postoperative cell counts in a rabbit. This novel approach may offer a promising solution to address the global shortage of corneal tissue worldwide. Histopathological evaluation concluded that no adverse reaction was detected in the eyes or systemically both at Subacute Systemic Toxicity (4 weeks), Biocompatibility testing demonstrated safety of the scaffold during cytotoxic and sensitization. Chronic Systemic Toxicity (6 months) and implantation testing showed no local tissue effects, no degradation or resorption (following ISO10993)First in human trial is anticipated in 2025.