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

Corneal blindness is one of the leading causes of blindness worldwide. For various infectious and non-infectious corneal diseases, current clinical repair strategies include corneal lesion debridement, conjunctival flap coverage, amniotic membrane transplantation, corneal transplantation, contact lens application, and injectable sealants. Injectable hydrogels, as smart materials that transition from a liquid precursor to a solid gel in response to external stimuli (e.g., light, temperature, or chemical cross-linking), enable precise filling of corneal defects via minimally invasive injection. They offer superior morphological adaptability, conforming tightly to irregular wound surfaces and achieving sutureless closure. Moreover, they promote regenerative repair of the epithelium, stroma, and nerves, significantly reducing patient discomfort, infection risk, recovery time, and healthcare costs, thereby advancing the paradigm of corneal repair from "transplant substitution" to "in situ regeneration."

Study Overview

• Status: Not yet recruiting
• Conditions: Corenal Diseases
• Intervention / Treatment: Biological: Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suxia Li; Phone Number: +86 158 5410 7085; Email: lsuxiasusu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• You must meet all the following inclusion criteria to participate in the study:

  1. Patients with corneal stromal defects, including those caused by trauma or following lesion excision for infection, with a residual stromal thickness of ≥300 μm in the defect area.
  2. Patients aged 18 to 85 years (inclusive, either sex) at the time of consent.
  3. Patients who are capable of providing written informed consent voluntarily to participate in the study.

Exclusion Criteria:

• You will be excluded from the study if you meet any of the following exclusion criteria:

  1. Patients with unexplained keratoconjunctival diseases.
  2. Patients with severe dry eye, symblepharon, corneal neovascularization, or other ocular surface disorders.
  3. Patients with systemic infectious diseases (positive for bacteria/fungi/HBV/HCV/HIV/TP, etc.).
  4. Patients with autoimmune diseases such as rheumatoid arthritis, Sjögren's syndrome, or graft-versus-host disease.
  5. Patients with uncontrolled ocular diseases in the study eye.
  6. Patients with major organ failure or other serious systemic conditions, including but not limited to cardiac insufficiency; poorly controlled diabetes mellitus (fasting blood glucose >8 mmol/L despite glucose-lowering therapy); uncontrolled stage II or higher hypertension (blood pressure >160/100 mmHg despite antihypertensive therapy); history of malignancy within the past 5 years; severe immunodeficiency, etc.
  7. Patients with psychiatric disorders that may interfere with treatment or evaluation.
  8. Pregnant or lactating women, or women planning to become pregnant during the clinical study.
  9. Patients deemed unsuitable for participation in the clinical trial by the investigator.
  10. Patients unable to complete follow-up visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sutureless Ophthalmic Hydrogel for Repairing Corneal Stromal Defects

Biological: Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects; Surgery was performed under peribulbar block anesthesia. After excision of the corneal lesion, the surface moisture of the recipient bed was dried with a sponge, and a cotton pad was placed over the pupillary area to protect the fundus. The hydrogel was pre-liquefied in a 37 °C water bath, then instilled into the lamellar defect using a sterile syringe, followed by irradiation with a 365 nm light source at an intensity of 18 mW/cm² for 30 seconds to achieve curing. A bandage contact lens could be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Ocular Adverse Events and Hydrogel-Related Ocular Complications (Irritation, Displacement, Infection, Corneal Cell/Epithelial Changes)	Description: Assess ocular safety outcomes including: Ocular surface irritation symptoms (eye redness, foreign body sensation, tearing, photophobia, etc.); Hydrogel adhesion status (presence or absence of hydrogel displacement or detachment); Corneal infection; Corneal endothelial cell morphology and density changes; Corneal epithelial healing time The incidence and severity of all events will be recorded.	1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Clarity Full Rating Scale (0-4 points full-scale assessment for corneal transparency after hydrogel repair)	Observe the transparency of the cornea in the hydrogel transplantation area using a slit lamp examination, score it, and record the corneal transparency scores at different follow-up time points. Full scale information: Minimum score = 0, Maximum score = 4; higher scores indicate worse corneal opacity/poorer corneal clarity, lower scores indicate better corneal transparency. Scoring criteria: 0 = completely transparent; = slight opacity, not easily detectable under direct illumination;; = mild opacity, visible under slit lamp;; = moderate opacity, partially obscuring the iris;; = severe opacity, obscuring details of intraocular structures.	1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Change in corneal thickness (OCT measurement, µm)	Use corneal OCT to observe changes in corneal thickness in the hydrogel transplantation area, and record the residual corneal thickness, hydrogel thickness, and total corneal thickness at different follow-up time points.	1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Change in visual acuity (decimal chart)	Use a decimal visual acuity chart to record the visual acuity and best corrected visual acuity at different follow-up time points, and evaluate the recovery and changes in visual acuity	1st day preoperatively, 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively

Collaborators and Investigators

• Sponsor: Suxia Li

Study record dates

Study Major Dates

• Study Start (Estimated): May 22, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SDSYKYY202510-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No