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A Single-Center Clinical Study on the Efficacy and Safety of a Sutureless Ophthalmic Hydrogel Adhesive for Ocular Surface Tissue Adhesion.

A Single-Center Clinical Study on the Efficacy and Safety of a Sutureless Ophthalmic Hydrogel Adhesive for Ocular Surface Tissue Adhesion.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122083
Enrollment
Unknown
Registered
2026-04-08
Start date
2026-04-08
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular surface diseases, including pterygium, corneal ulcer, and ocular surface burns.

Interventions

Hydrogel Adhesion Group:Adhering ocular surface tissue with hydrogel.

Sponsors

Eye Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients for whom surgical adhesion of ocular surface tissue is indicated due to conditions such as pterygium, corneal ulcer, ocular surface burn, or pseudopterygium, involving procedures like conjunctival flap adhesion, amniotic membrane transplantation, or keratoplasty. 2. Aged 18–85 years (any gender) at the time of consent. 3. Ability to provide written informed consent for voluntary participation in the study. 4. Absence of severe systemic organic diseases, including but not limited to severe cardiac, hepatic, renal disorders, and malignant tumors.

Exclusion criteria

Exclusion criteria: 1. Patients with a known allergy or hypersensitivity to any component of the sutureless ophthalmic hydrogel (e.g., decellularized porcine corneal stroma, gelatin methacryloyl) or to any peri-/post-operative medication prescribed (e.g., anesthetics, antibiotics, steroids). 2. Patients with active systemic infection (e.g., bacterial, fungal, or viral infections such as HBV or HCV positivity). 3. Diabetic patients with poor glycemic control (HbA1c > 8.0%). 4. Pregnant or lactating women, women of childbearing potential not using adequate contraception, or women planning to become pregnant during the study period. 5. Patients who have participated in any other clinical trial or investigational study within one month prior to the screening visit. 6. Patients deemed by the investigator to be unsuitable for participation in this clinical study due to other comorbidities or reasons.

Design outcomes

Primary

MeasureTime frame
Ocular Irritation Score;Conjunctival Redness Score;IOP(mmHg);

Secondary

MeasureTime frame
Condition of Conjunctival Flap Adhesion;Vision;

Countries

China

Contacts

Public ContactWeiyun Shi

Eye Hospital of Shandong First Medical University

weiyunshi@163.com+86 531 8127 6002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026