Corenal Diseases
Conditions
Brief summary
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."
Interventions
BIOLOGICALSutureless 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.
Sponsors
Suxia Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ocular Adverse Events and Hydrogel-Related Ocular Complications (Irritation, Displacement, Infection, Corneal Cell/Epithelial Changes) | 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
| Measure | Time frame | Description |
|---|---|---|
| Corneal Clarity Full Rating Scale (0-4 points full-scale assessment for corneal transparency after hydrogel repair) | 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; 1. = slight opacity, not easily detectable under direct illumination; 2. = mild opacity, visible under slit lamp; 3. = moderate opacity, partially obscuring the iris; 4. = severe opacity, obscuring details of intraocular structures. |
| Change in corneal thickness (OCT measurement, µm) | 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) | 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 |
Contacts
CONTACTSuxia Li
Outcome results
None listed