Clinical Trial

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

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT07608367
Lead Sponsor Suxia Li
Conditions Cornea Disease
Enrollment 20 participants
Start Date 2026-05-22
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-27