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NCT Number: NCT07608367

A Single-Center Clinical Study to Evaluate the Efficacy and Safety of a Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion

When severe ocular surface lesions occur (e.g., pterygium, corneal ulcer, ocular surface burn, etc.), the currently clinically common surgical procedures such as conjunctival flap coverage, amniotic membrane transplantation, and keratoplasty are primarily fixed by suturing. However, suturing has numerous drawbacks. On the one hand, the suturing process causes additional mechanical damage to ocular surface tissues, triggers local inflammatory responses, and increases postoperative discomfort such as pain and foreign body sensation. Moreover, uneven suture tension is prone to cause conjunctival flap shrinkage or displacement, impairing the repair effect. On the other hand, postoperative suture irritation continuously activates fibroblast proliferation, leading to excessive deposition of subconjunctival collagen and the formation of dense scar tissue, which in turn compromises the stability of the ocular surface tear film and visual quality. This study intends to develop a suture-free ophthalmic hydrogel for conjunctival flap adhesion. By combining the natural biological activity of decellularized porcine corneal matrix with the photocrosslinking properties of GelMA, and integrating low-energy visible light (465nm) curing technology, the hydrogel enables rapid, firm, and suture-free adhesion of conjunctival flaps.

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Key information

Conditions

Cornea Disease Corneal Diseases Eye Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Aged 18 to 85 years old at the time of informed consent (regardless of gender).
  • Able to provide written informed consent and voluntarily participate in the study.
  • No severe systemic organic diseases, such as severe heart, liver, kidney diseases, and malignant tumors.

Exclusion criteria

  • 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.).
  • Patients with systemic infectious diseases (bacterial, fungal, positive for HBV, HCV and other viruses, etc.).
  • Diabetic patients with poor blood glucose control (HbA1C ≥ 8.0%).
  • Pregnant women, women who may be pregnant, or women planning to become pregnant during the clinical study.
  • Patients who have participated in other clinical trials or studies within 1 month before obtaining informed consent.
  • Other patients deemed unsuitable for the clinical study due to comorbidities.

Treatment and study plan

Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery

Biological

Surgical treatment with hydrogel

Primary outcomes

  1. Safety Evaluation Items

    Time frame: 1 month postoperatively

    Observation of ocular surface irritation symptoms (foreign body sensation, pain, photophobia, lacrimation, etc.), immunogenicity, sensitization, elevated intraocular pressure (IOP), ocular infection, conjunctival hyperemia, and other conditions.

Secondary outcomes

  1. Conjunctival flap adhesion effect

    Time frame: 1st day, 1st week, and 1st month postoperatively

    The fitting status of the conjunctival flap was observed under a slit-lamp microscope to assess the presence of displacement or detachment, and the time of complete conjunctival flap adhesion was recorded.

  2. Ocular surface repair status

    Time frame: 1st week and 1st month postoperatively

    The changes in conjunctival flap thickness were examined by anterior segment optical coherence tomography (OCT), and the conjunctival epithelial healing was observed; fluorescein staining was used to evaluate the integrity of the ocular surface epithelium, and the time of complete epithelial coverage was recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Suxia Lo

CONTACT

[email protected]

+86 158 5410 7085

Sponsors and collaborators

Lead sponsor

Suxia Li

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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