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

Обзор

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.

Вмешательства

• Биопрепарат Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery
  Surgical treatment with hydrogel

Первичные конечные точки

• Safety Evaluation Items [Срок оценки: 1 month postoperatively]

Вторичные конечные точки (2)

• Conjunctival flap adhesion effect [Срок оценки: 1st day, 1st week, and 1st month postoperatively]
• Ocular surface repair status [Срок оценки: 1st week and 1st month postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Китай · 1 центр

• Shandong Eye Hospital — Цзинань

Идентификаторы

NCT: NCT07608367 · SDSYKYY202510-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗