ArticleScientific reports2026
Deep-stromal implantation of a double-crosslinked bioengineered porcine collagen implant (BPCDX) in advanced keratoconus: a 12-month study of corneal remodeling and visual outcomes.
Article in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
To evaluate the efficacy of the Bioengineered Porcine Collagen, Double-Crosslinked (BPCDX) Implant in patients with advanced keratoconus (KCN). This study included 17 eyes of 17 patients (mean age = 32.29 ± 9.21 years) with stage 3–4 KCN. A BPCDX implant (type I collagen derived from porcine skin; thickness 280–440 μm, 8.00 mm diameter) was inserted into the deep corneal stromal pocket created at 60–70% of the preoperative thinnest corneal thickness, preserving approximately 100 μm of posterior cornea. The pocket and a 3.5-mm temporal incision were created using a femtosecond laser (VisuMax platform, Carl Zeiss Meditec AG, Germany). Assessments including uncorrected (UCVA) and best-corrected visual acuity (BCVA), refractive error, corneal thickness and curvature, and anterior chamber depth (ACD) were performed preoperatively, and at 1 and 12 months postoperatively. At 12 months, central corneal thickness increased from 417 μm to 698 μm, and thinnest pachymetry rose from 370 μm to 661 μm. Sphere improved from − 6.54 ± 5.89 to − 3.73 ± 3.99 D (p = 0.003), and spherical equivalent from − 9.85 ± 6.52 to − 6.19 ± 3.37 D (p = 0.008). During this time, UCVA improved from 1.24 ± 0.27 to 0.92 ± 0.27 logMAR (p = 0.023); BCVA also improved from 0.54 ± 0.26 to 0.42 ± 0.20 logMAR (p = 0.07). One year after BPCDX implantation, the mean changes in anterior flat and steep keratometry were − 6.75 ± 4.29 and − 6.02 ± 6.18, respectively (both p < 0.05). Besides, Anterior maximum keratometry decreased from 70.62 ± 8.32 to 61.65 ± 5.38 D (p = 0.004). ACD also decreased slightly from 3.62 ± 0.49 to 3.33 ± 0.53 mm (p = 0.006). No serious intraoperative or postoperative complications occurred over 12 months. Stromal implantation of BPCDX effectively reconstructs corneal shape and improves visual and refractive outcomes in advanced KCN, with a favorable safety profile. These results support its potential as a minimally invasive alternative to penetrating keratoplasty, warranting further investigation in larger, controlled trials.
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