Sutureless Ophthalmic Hydrogel for Corneal Wound Repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, single-center study examines the safety and potential effectiveness of a sutureless ophthalmic hydrogel for repairing corneal stromal defects. The hydrogel is injected to fill irregular corneal wounds and then solidifies, aiming to promote epithelial, stromal, and nerve repair without sutures. Eligible participants are adults with focal corneal stromal defects of at least 300 micrometers thickness, within 18 to 85 years old, who can consent. Exclusion criteria include other ocular surface diseases, significant systemic infections, and certain autoimmune conditions. The study is conducted at Shandong Eye Hospital in Jinan, China, led by Suxia Li without listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shandong Eye Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Suxia Li
• Email: lsuxiasusu@163.com
• Phone: +86 158 5410 7085

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Suture-free hydrogel to help fix the eye surface after surgery

  This study tests a suture-free hydrogel to help seal and protect the eye surface after procedures like flap adhesion or transplantation in adults with cornea-related conditions.

  Recruiting Shandong Eye Hospital · Jinan, Shandong · NCT07608367

• Autologous urine-derived epithelial cells to treat corneal endothelial cell dysfunction

  This study tests injecting a patient’s own urine-derived epithelial cells into the eye to help the cornea heal in people with corneal endothelial cell dysfunction.

  Recruiting Shandong Eye Hospital · Jinan, Shandong · NCT07435142

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.