NCT07638215|Recruiting
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Sponsor study identifier
interventional
30
1 country
1
Study Start
September 1, 2025
Actual (reported)Primary Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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."
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2025
Actual (reported)April 19, 2026
Actual (reported)June 10, 2026
Actual (reported)January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Change in corneal thickness (OCT measurement, µm)
1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Change in visual acuity (decimal chart)
1st day preoperatively, 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Shandong Eye Hospital
Jinan, Shandong, 250021, China
First Submitted
April 19, 2026
First Posted
June 10, 2026
Study Start
September 1, 2025
Actual (reported)Primary Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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