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

NCT07608367 | Not Yet Recruiting

• 1 other identifier: SDSYKYY202510-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cornea Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Conjunctival flap adhesion effect

  1st day, 1st week, and 1st month postoperatively

• Ocular surface repair status

  1st week and 1st month postoperatively

Study Arms (1)

Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion Therapy

EXPERIMENTAL

A Single-Center Clinical Study

Biological: Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery

Interventions

Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery BIOLOGICAL

Surgical treatment with hydrogel

Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suxia Li: lead

Study Sites (1)

Shandong Eye Hospital

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Suxia Lo

CONTACT

+86 158 5410 7085; lsuxiasusu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 27, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)