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

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 study evaluates a suture-free ophthalmic hydrogel designed to secure ocular surface repairs without traditional sutures. Eligible adults with corneal disease undergoing conjunctival flap adhesion, amniotic membrane transplantation, or keratoplasty will receive the hydrogel as part of the surgical repair. The trial aims to assess safety and potential benefits in tissue adhesion and healing, avoiding suture-related tissue trauma and inflammation. Outcomes will help determine if the hydrogel can simplify procedures and improve recovery for ocular surface surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with ocular surface diseases (e.g., pterygium, corneal ulcer, ocular surface burn, pseudopterygium, etc.) who need to undergo conjunctival flap adhesion, amniotic membrane transplantation, or keratoplasty.
2. Aged 18 to 85 years old at the time of informed consent (regardless of gender).
3. Able to provide written informed consent and voluntarily participate in the study.
4. No severe systemic organic diseases, such as severe heart, liver, kidney diseases, and malignant tumors.

Exclusion Criteria:

1. A history of allergy to the components of the suture-free ophthalmic hydrogel (e.g., decellularized porcine corneal matrix, GelMA, etc.) or the drugs prescribed during the perioperative and postoperative observation periods (anesthetics, antibiotics, steroid preparations, etc.).
2. Patients with systemic infectious diseases (bacterial, fungal, positive for HBV, HCV and other viruses, etc.).
3. Diabetic patients with poor blood glucose control (HbA1C ≥ 8.0%).
4. Pregnant women, women who may be pregnant, or women planning to become pregnant during the clinical study.
5. Patients who have participated in other clinical trials or studies within 1 month before obtaining informed consent.
6. Other patients deemed unsuitable for the clinical study due to comorbidities.

Where it's running

• Shandong Eye Hospital
  Jinan, Shandong, China Recruiting

Study contacts

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

Similar studies

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

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• Using laser treatment to manage glaucoma in patients receiving a Boston keratoprosthesis

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• Sutureless Ophthalmic Hydrogel for Corneal Wound Repair

  This study tests a sutureless hydrogel injected into corneal wounds to see if it safely helps repair the cornea in adults with stromal defects.

  Recruiting Shandong Eye Hospital · Jinan, Shandong · NCT07638215

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.