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

2026年6月4日 更新者：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."

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Sutureless Ophthalmic Hydrogel for Repairing Corneal Stromal Defects
生物：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Ocular Adverse Events and Hydrogel-Related Ocular Complications (Irritation, Displacement, Infection, Corneal Cell/Epithelial Changes)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Corneal Clarity Full Rating Scale (0-4 points full-scale assessment for corneal transparency after hydrogel repair)
大体时间：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)
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Suxia Li

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月22日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年4月19日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年6月4日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • SDSYKYY202510-2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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