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临床试验/NCT07608367
NCT07608367尚未招募不适用

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

Suxia Li1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年5月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.
  • Aged 18 to 85 years old at the time of informed consent (regardless of gender).
  • Able to provide written informed consent and voluntarily participate in the study.
  • No severe systemic organic diseases, such as severe heart, liver, kidney diseases, and malignant tumors.

排除标准

  • 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.).
  • Patients with systemic infectious diseases (bacterial, fungal, positive for HBV, HCV and other viruses, etc.).
  • Diabetic patients with poor blood glucose control (HbA1C ≥ 8.0%).
  • Pregnant women, women who may be pregnant, or women planning to become pregnant during the clinical study.
  • Patients who have participated in other clinical trials or studies within 1 month before obtaining informed consent.
  • Other patients deemed unsuitable for the clinical study due to comorbidities.

研究者

发起方
Suxia Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Suxia Li

Prof.

Shandong Eye Hospital

研究点 (1)

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