Degradable Suture-Free Scaffold to Induce Therapeutic Ridge Formation and to Control Eye Elongation: A Potential Treatment for Pathological Myopia

Purpose: The purpose of this study was to develop an optimized treatment for pathological myopia: a degradable cell-free suture-free tissue scaffold implant that reverses the excessive axial elongation and induces a therapeutic ridge. Methods: A form-deprivation (FD) myopia model was established in New Zealand White rabbits. Comprised of gelatin methacryloyl and a poly-L-lactide microfiber film, the tissue scaffold was implanted onto the posterior sclera of FD eyes (model + implant group; n =12), compared with model-only (n = 12) and controls eyes (n = 24). Ocular dimensions were monitored via ultrasound. Safety was assessed by electroretinogram, intraocular pressure, and apoptosis assays. The histology structure of regenerated tissue and sclera was shown. Results: The axial length in model + implant eyes was significantly shorter than model-only eyes and the control eyes since 2 weeks after the implantation (13.79 ± 0.23 mm, 15.15 ± 0.33 mm, and 14.70 ± 0.18 mm, P < 0.001) and maintained. The scaffold prompted the in situ regeneration of tissue mimicking the pseudo-lamellar arrangement of collagen fibers and major cell types found in native sclera, which formed an inward therapeutic ridge at the posterior sclera. The simulation indicated the ridge relieved outward macular traction significantly with minimum perturbation to stress distribution outside the central macula. Furthermore, collagen synthesis was prompted within the sclera itself. Conclusions: This innovative strategy, which avoids the long-term complications of foreign body compression, suturing, or tension fixation, effectively reversed myopic eye elongation and induced a therapeutic ridge. Translational Relevance: Demonstration of a degradable scaffold implantation as a treatment for pathological myopia with potential for minimally invasive clinical application was presented.