<p>Persistent corneal epithelial defects (PEDs) and microbial keratitis are major contributors to vision loss. Current treatments, including topical eye drops, are constrained by low bioavailability and inadequate patient adherence. This study introduces a multifunctional, biocompatible contact lens composed of gelatin (G), amniotic membrane (AM), and the antimicrobial peptide CM11 (P). It is specifically developed to promote corneal healing and provide sustained drug delivery. Three hydrogel scaffolds (G, G-AM, and G-AM-P) were fabricated and systematically characterized, with emphasis on peptide release dynamics, antibacterial performance, and cytocompatibility, as these parameters are central to their therapeutic functionality. In vivo efficacy and safety were evaluated in a rabbit model using slit-lamp examination, anterior segment optical coherence tomography, and histopathological analysis. G-AM-P demonstrated acceptable optical clarity, significant porosity (~ 94%), moderate hydrophilicity (contact angle ≈ 70°), and an elastic modulus of ~ 0.55&#xa0;MPa. Also, a biphasic release characterized by an initial rapid phase followed by plateau for up to 72&#xa0;h. G-AM-P inhibited <i>Staphylococcus aureus</i> with a 15&#xa0;mm zone of inhibition. This scaffold showed no cytotoxicity on the human corneal epithelial cells with viability exceeding 80%, after 72&#xa0;h. In rabbits, G-AM-P exhibited ocular tolerance, facilitated re-epithelialization, and did not provoke inflammation, neovascularization, or stromal haze. This study demonstrates, the development of a protein-releasing G-AM-P therapeutic contact lens that integrates optical transparency, mechanical robustness, biocompatibility, and targeted antibacterial activity against Gram-positive pathogens. These findings highlight its potential as a promising platform for corneal epithelial repair with in vitro antibacterial activity, supporting further investigation toward clinical translation. </p>

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A novel bioactive contact lens for corneal epithelial regeneration in a rabbit model

  • Naghmeh Rafati,
  • Azadeh Asefnejad,
  • Saeed Heidari-Keshel,
  • Hossein Aghamollaei

摘要

Persistent corneal epithelial defects (PEDs) and microbial keratitis are major contributors to vision loss. Current treatments, including topical eye drops, are constrained by low bioavailability and inadequate patient adherence. This study introduces a multifunctional, biocompatible contact lens composed of gelatin (G), amniotic membrane (AM), and the antimicrobial peptide CM11 (P). It is specifically developed to promote corneal healing and provide sustained drug delivery. Three hydrogel scaffolds (G, G-AM, and G-AM-P) were fabricated and systematically characterized, with emphasis on peptide release dynamics, antibacterial performance, and cytocompatibility, as these parameters are central to their therapeutic functionality. In vivo efficacy and safety were evaluated in a rabbit model using slit-lamp examination, anterior segment optical coherence tomography, and histopathological analysis. G-AM-P demonstrated acceptable optical clarity, significant porosity (~ 94%), moderate hydrophilicity (contact angle ≈ 70°), and an elastic modulus of ~ 0.55 MPa. Also, a biphasic release characterized by an initial rapid phase followed by plateau for up to 72 h. G-AM-P inhibited Staphylococcus aureus with a 15 mm zone of inhibition. This scaffold showed no cytotoxicity on the human corneal epithelial cells with viability exceeding 80%, after 72 h. In rabbits, G-AM-P exhibited ocular tolerance, facilitated re-epithelialization, and did not provoke inflammation, neovascularization, or stromal haze. This study demonstrates, the development of a protein-releasing G-AM-P therapeutic contact lens that integrates optical transparency, mechanical robustness, biocompatibility, and targeted antibacterial activity against Gram-positive pathogens. These findings highlight its potential as a promising platform for corneal epithelial repair with in vitro antibacterial activity, supporting further investigation toward clinical translation.