此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

A Single-Center Clinical Study to Evaluate the Efficacy and Safety of a Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion

2026年5月20日 更新者:Suxia Li
When severe ocular surface lesions occur (e.g., pterygium, corneal ulcer, ocular surface burn, etc.), the currently clinically common surgical procedures such as conjunctival flap coverage, amniotic membrane transplantation, and keratoplasty are primarily fixed by suturing. However, suturing has numerous drawbacks. On the one hand, the suturing process causes additional mechanical damage to ocular surface tissues, triggers local inflammatory responses, and increases postoperative discomfort such as pain and foreign body sensation. Moreover, uneven suture tension is prone to cause conjunctival flap shrinkage or displacement, impairing the repair effect. On the other hand, postoperative suture irritation continuously activates fibroblast proliferation, leading to excessive deposition of subconjunctival collagen and the formation of dense scar tissue, which in turn compromises the stability of the ocular surface tear film and visual quality. This study intends to develop a suture-free ophthalmic hydrogel for conjunctival flap adhesion. By combining the natural biological activity of decellularized porcine corneal matrix with the photocrosslinking properties of GelMA, and integrating low-energy visible light (465nm) curing technology, the hydrogel enables rapid, firm, and suture-free adhesion of conjunctival flaps.

研究概览

研究类型

介入性

注册 (估计的)

20

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

学习地点

    • Shandong
      • Jinan、Shandong、中国
        • Shandong Eye Hospital
        • 接触:

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:

  1. Patients with ocular surface diseases (e.g., pterygium, corneal ulcer, ocular surface burn, pseudopterygium, etc.) who need to undergo conjunctival flap adhesion, amniotic membrane transplantation, or keratoplasty.
  2. Aged 18 to 85 years old at the time of informed consent (regardless of gender).
  3. Able to provide written informed consent and voluntarily participate in the study.
  4. No severe systemic organic diseases, such as severe heart, liver, kidney diseases, and malignant tumors.

Exclusion Criteria:

  1. A history of allergy to the components of the suture-free ophthalmic hydrogel (e.g., decellularized porcine corneal matrix, GelMA, etc.) or the drugs prescribed during the perioperative and postoperative observation periods (anesthetics, antibiotics, steroid preparations, etc.).
  2. Patients with systemic infectious diseases (bacterial, fungal, positive for HBV, HCV and other viruses, etc.).
  3. Diabetic patients with poor blood glucose control (HbA1C ≥ 8.0%).
  4. Pregnant women, women who may be pregnant, or women planning to become pregnant during the clinical study.
  5. Patients who have participated in other clinical trials or studies within 1 month before obtaining informed consent.
  6. Other patients deemed unsuitable for the clinical study due to comorbidities.

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:Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion Therapy
A Single-Center Clinical Study
Surgical treatment with hydrogel

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
Safety Evaluation Items
大体时间:1 month postoperatively
Observation of ocular surface irritation symptoms (foreign body sensation, pain, photophobia, lacrimation, etc.), immunogenicity, sensitization, elevated intraocular pressure (IOP), ocular infection, conjunctival hyperemia, and other conditions.
1 month postoperatively

次要结果测量

结果测量
措施说明
大体时间
Conjunctival flap adhesion effect
大体时间:1st day, 1st week, and 1st month postoperatively
The fitting status of the conjunctival flap was observed under a slit-lamp microscope to assess the presence of displacement or detachment, and the time of complete conjunctival flap adhesion was recorded.
1st day, 1st week, and 1st month postoperatively
Ocular surface repair status
大体时间:1st week and 1st month postoperatively
The changes in conjunctival flap thickness were examined by anterior segment optical coherence tomography (OCT), and the conjunctival epithelial healing was observed; fluorescein staining was used to evaluate the integrity of the ocular surface epithelium, and the time of complete epithelial coverage was recorded.
1st week and 1st 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

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10日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月27日

研究记录更新

最后更新发布 (实际的)

2026年5月27日

上次提交的符合 QC 标准的更新

2026年5月20日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SDSYKYY202510-1

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.

订阅