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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sutureless Ophthalmic Hydrogel for Repairing Corneal Stromal Defects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
| 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively |
| 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;
|
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Inclusion Criteria:
You must meet all the following inclusion criteria to participate in the study:
Exclusion Criteria:
You will be excluded from the study if you meet any of the following exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suxia Li | Contact | +86 158 5410 7085 | lsuxiasusu@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2026 | Jun 4, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2026 | Jun 4, 2026 | ICF_001.pdf |
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| 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 |