Cornea DiseaseNCT07608367
A Single-Center Clinical Study to Evaluate the Efficacy and Safety of a Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion
A study testing Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery in people with Cornea Disease, run by Suxia Li at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cornea Disease
- What is being tested?
- Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Eye Hospital
Jinan, Shandong
Suxia Li, +86 158 5410 7085, lsuxiasusu@163.com
About this study
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.
- Conditions
- Cornea Disease
- Being tested
- Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture-Free Ophthalmic Hydrogel for Ocular Surface SurgeryBiological
Surgical treatment with hydrogel
| Study group | Role | What they receive |
|---|---|---|
| Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion Therapy | Experimental | A Single-Center Clinical Study Receives: Biological: Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation Items
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.
Measured: 1 month postoperatively
Secondary outcomes (2)
Conjunctival flap adhesion effect
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.
Measured: 1st day, 1st week, and 1st month postoperatively
Ocular surface repair status
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.
Measured: 1st week and 1st month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Oct 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cornea DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suxia Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suxia Li, Shandong Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608367
- Sponsor's protocol ID
- SDSYKYY202510-1
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Clinical Study to Evaluate the Efficacy and Safety of a Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion
- ClinicalTrials.gov ID
- NCT07608367
- Acronym / sponsor ID
- SDSYKYY202510-1
- Conditions
- Cornea Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Suxia LiUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion Therapy | Experimental | Biological: Suture-Free Ophthalmic Hydrogel for Ocular Surface SurgeryA Single-Center Clinical Study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suture-Free Ophthalmic Hydrogel for Ocular Surface SurgerySurgical treatment with hydrogel | Biological | Suture-Free Ophthalmic Hydrogel for Ocular Surface Tissue Adhesion Therapy |
Primary outcome
Safety Evaluation Items
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture-Free Ophthalmic Hydrogel for Ocular Surface Surgery in people with Cornea Disease, run by Suxia Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suxia Lo (+86 158 5410 7085, lsuxiasusu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation Items (time frame: 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.