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Not yet recruiting NCT07608367

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

No phase Interventional Cornea Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery.
Who it may be relevant to
Registry conditions: Cornea Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Safety Evaluation Items [Time frame: 1 month postoperatively]
Secondary outcome measures (2)
  • Conjunctival flap adhesion effect [Time frame: 1st day, 1st week, and 1st month postoperatively]
  • Ocular surface repair status [Time frame: 1st week and 1st month postoperatively]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shandong Eye Hospital — Jinan

Identifiers

NCT: NCT07608367 · SDSYKYY202510-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗