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

4. juni 2026 oppdatert av: Suxia Li
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."

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sutureless Ophthalmic Hydrogel for Repairing Corneal Stromal Defects
Biologisk: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Ocular Adverse Events and Hydrogel-Related Ocular Complications (Irritation, Displacement, Infection, Corneal Cell/Epithelial Changes)
Tidsramme: 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.
1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Corneal Clarity Full Rating Scale (0-4 points full-scale assessment for corneal transparency after hydrogel repair)
Tidsramme: 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.
1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Change in corneal thickness (OCT measurement, µm)
Tidsramme: 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.
1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Change in visual acuity (decimal chart)
Tidsramme: 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
1st day preoperatively, 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Suxia Li

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

22. mai 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

19. april 2026

Først innsendt som oppfylte QC-kriteriene

4. juni 2026

Først lagt ut (Faktiske)

10. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • SDSYKYY202510-2

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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