About this trial
Corneal blindness is one of the leading causes of blindness worldwide. For various infectious and non-infectious corneal diseases, current clinical repair strategies include corneal lesion debridement, conjunctival flap coverage, amniotic membrane transplantation, corneal transplantation, contact lens application, and injectable sealants. Injectable hydrogels, as smart materials that transition from a liquid precursor to a solid gel in response to external stimuli (e.g., light, temperature, or chemical cross-linking), enable precise filling of corneal defects via minimally invasive injection. They offer superior morphological adaptability, conforming tightly to irregular wound surfaces and achieving sutureless closure. Moreover, they promote regenerative repair of the epithelium, stroma, and nerves, significantly reducing patient discomfort, infection risk, recovery time, and healthcare costs, thereby advancing the paradigm of corneal repair from "transplant substitution" to "in situ regeneration."
Eligibility criteria
Qualifiers
Patients with corneal stromal defects, including those caused by trauma or following lesion excision for infection, with a residual stromal thickness of ≥300 μm in the defect area.
Patients aged 18 to 85 years (inclusive, either sex) at the time of consent.
Patients who are capable of providing written informed consent voluntarily to participate in the study.
Disqualifiers
Patients with unexplained keratoconjunctival diseases.
Patients with severe dry eye, symblepharon, corneal neovascularization, or other ocular surface disorders.
Patients with systemic infectious diseases (positive for bacteria/fungi/HBV/HCV/HIV/TP, etc.).
Patients with autoimmune diseases such as rheumatoid arthritis, Sjögren's syndrome, or graft-versus-host disease.
Trial design
Treatments tested in this trial
- Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects
Treatment groups
Locations
Sponsors and collaborators
Suxia Li
Lead sponsor
Shandong Eye Hospital
Sponsor institution