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A Single-Center Clinical Study Evaluating the Efficacy and Safety of a Sutureless Ophthalmic Hydrogel for Corneal Wound Repair

A Single-Center Clinical Study Evaluating the Efficacy and Safety of a Sutureless Ophthalmic Hydrogel for Corneal Wound Repair

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114182
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Ocular Surface Diseases (Corneal Stromal Defect)

Interventions

Hydrogel Repair Group:Repairing defective corneal stroma with hydrogel

Sponsors

Eye Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with corneal stromal defects, including those caused by trauma or following infectious lesion excision, with a residual corneal thickness of =400 microns in the defect area. 2. Patients aged 18 to 85 years (inclusive) at the time of consent acquisition, regardless of gender. 3. Patients capable of providing written informed consent voluntarily to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients with keratoconjunctival diseases of unknown etiology. 2. Patients with severe ocular surface diseases, including severe dry eye, symblepharon, corneal neovascularization, etc. 3. Patients with systemic infectious diseases (positive for bacteria, fungi, HBV, HCV, HIV, TP, or other viruses). 4. Patients with systemic autoimmune diseases, such as rheumatoid arthritis, Sjögren's syndrome, graft-versus-host disease, etc. 5. Subjects with other uncontrolled ocular diseases in the study eye. 6. Patients with failure of major organ functions or other severe systemic conditions, such as cardiac insufficiency; severe diabetes (fasting blood glucose >8 mmol/L despite glucose-lowering measures); uncontrolled hypertension stage II or above (blood pressure >160/100 mmHg despite medication); history of malignant tumor (within 5 years); severe immunodeficiency, etc. 7. Subjects with psychiatric disorders that may interfere with treatment or evaluation. 8. Pregnant or breastfeeding women, or women planning to become pregnant during the clinical study period. 9. Subjects deemed unsuitable for participation in this clinical trial by the investigator. 10. Patients unable to complete follow-up visits.

Design outcomes

Primary

MeasureTime frame
Corenal Thickness;Vision;IOP;

Secondary

MeasureTime frame
Corneal Topography;Corneal Epithelial Healing ;

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: Feb 4, 2026