Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion Therapy | Experimental | A Single-Center Clinical Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery | Biological | Surgical treatment with hydrogel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation Items | 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. | 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival flap adhesion effect | 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. | 1st day, 1st week, and 1st month postoperatively |
| Ocular surface repair status |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suxia Lo | Contact | +86 158 5410 7085 | lsuxiasusu@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Eye Hospital | Jinan | Shandong | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2026 | Apr 10, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 1st week and 1st month postoperatively |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2026 | Apr 17, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2026 | Apr 10, 2026 | ICF_002.pdf |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided