A Single-Center Clinical Study to Evaluate the Efficacy and Safety of Sutureless Ophthalmic Hydrogel for Corneal Wound Repair

Inclusion Criteria:

• You must meet all the following inclusion criteria to participate in the study:

  1. 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.
  2. Patients aged 18 to 85 years (inclusive, either sex) at the time of consent.
  3. Patients who are capable of providing written informed consent voluntarily to participate in the study.

Exclusion Criteria:

• You will be excluded from the study if you meet any of the following exclusion criteria:

  1. Patients with unexplained keratoconjunctival diseases.
  2. Patients with severe dry eye, symblepharon, corneal neovascularization, or other ocular surface disorders.
  3. Patients with systemic infectious diseases (positive for bacteria/fungi/HBV/HCV/HIV/TP, etc.).
  4. Patients with autoimmune diseases such as rheumatoid arthritis, Sjögren's syndrome, or graft-versus-host disease.
  5. Patients with uncontrolled ocular diseases in the study eye.
  6. Patients with major organ failure or other serious systemic conditions, including but not limited to cardiac insufficiency; poorly controlled diabetes mellitus (fasting blood glucose >8 mmol/L despite glucose-lowering therapy); uncontrolled stage II or higher hypertension (blood pressure >160/100 mmHg despite antihypertensive therapy); history of malignancy within the past 5 years; severe immunodeficiency, etc.
  7. Patients with psychiatric disorders that may interfere with treatment or evaluation.
  8. Pregnant or lactating women, or women planning to become pregnant during the clinical study.
  9. Patients deemed unsuitable for participation in the clinical trial by the investigator.
  10. Patients unable to complete follow-up visits.