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NCT Number: NCT07638215

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."

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Key information

Conditions

Corenal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.
Patients aged 18 to 85 years (inclusive, either sex) at the time of consent.
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:

Patients with unexplained keratoconjunctival diseases.
Patients with severe dry eye, symblepharon, corneal neovascularization, or other ocular surface disorders.
Patients with systemic infectious diseases (positive for bacteria/fungi/HBV/HCV/HIV/TP, etc.).
Patients with autoimmune diseases such as rheumatoid arthritis, Sjögren's syndrome, or graft-versus-host disease.
Patients with uncontrolled ocular diseases in the study eye.
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.
Patients with psychiatric disorders that may interfere with treatment or evaluation.
Pregnant or lactating women, or women planning to become pregnant during the clinical study.
Patients deemed unsuitable for participation in the clinical trial by the investigator.
Patients unable to complete follow-up visits.

Treatment and study plan

Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects

Biological

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.

Primary outcomes

Incidence of Ocular Adverse Events and Hydrogel-Related Ocular Complications (Irritation, Displacement, Infection, Corneal Cell/Epithelial Changes)

Time frame: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
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.

Secondary outcomes

Corneal Clarity Full Rating Scale (0-4 points full-scale assessment for corneal transparency after hydrogel repair)

Time frame: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
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.
Change in corneal thickness (OCT measurement, µm)

Time frame: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively

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.
Change in visual acuity (decimal chart)

Time frame: 1st day preoperatively, 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively

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

Study contacts

Contact information is provided by the study sponsor or research team.

Suxia Li

CONTACT

[email protected]

+86 158 5410 7085

Sponsors and collaborators

Lead sponsor

Suxia Li

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 10, 2026
Registry last updated: Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.