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

Обзор

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."

Вмешательства

• Биопрепарат 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 b

Первичные конечные точки

• Incidence of Ocular Adverse Events and Hydrogel-Related Ocular Complications (Irritation, Displacement, Infection, Corneal Cell/Epithelial Changes) [Срок оценки: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07638215 · SDSYKYY202510-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗