Corenal DiseasesNCT07638215
A Single-Center Clinical Study to Evaluate the Efficacy and Safety of Sutureless Ophthalmic Hydrogel for Corneal Wound Repair
A study testing Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects in people with Corenal Diseases, run by Suxia Li at 1 site in China.
Trial summary
Corneal blindness is one of the leading causes of blindness worldwide. For various infectious and non-infectious corneal diseases, current clinical repair strategies include corneal lesion debridement, conjunctival flap coverage, amniotic membrane transplantation, corneal transplantation, contact lens application, and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Corenal Diseases
- What is being tested?
- Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 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
- You must meet all the following inclusion criteria to participate in the study:
- Patients with corneal stromal defects, including those caused by trauma or following lesion excision for infection, with a residual stromal thickness of ≥300 μm in the defect area.
- Patients aged 18 to 85 years (inclusive, either sex) at the time of consent.
- Patients who are capable of providing written informed consent voluntarily to participate in the study.
Who cannot join
- You will be excluded from the study if you meet any of the following exclusion criteria:
- Patients with unexplained keratoconjunctival diseases.
- Patients with severe dry eye, symblepharon, corneal neovascularization, or other ocular surface disorders.
- Patients with systemic infectious diseases (positive for bacteria/fungi/HBV/HCV/HIV/TP, etc.).
- Patients with autoimmune diseases such as rheumatoid arthritis, Sjögren's syndrome, or graft-versus-host disease.
- Patients with uncontrolled ocular diseases in the study eye.
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- Patients with major organ failure or other serious systemic conditions, including but not limited to cardiac insufficiency; poorly controlled diabetes mellitus (fasting blood glucose >8 mmol/L despite glucose-lowering therapy); uncontrolled stage II or higher hypertension (blood pressure >160/100 mmHg despite antihypertensive therapy); history of malignancy within the past 5 years; severe immunodeficiency, etc.
- Patients with psychiatric disorders that may interfere with treatment or evaluation.
- Pregnant or lactating women, or women planning to become pregnant during the clinical study.
- Patients deemed unsuitable for participation in the clinical trial by the investigator.
- Patients unable to complete follow-up visits.
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, 250021
Su xia Li, PhD, 13705312702, hgao@sdfmu.edu.cn
About this study
Corneal blindness is one of the leading causes of blindness worldwide. For various infectious and non-infectious corneal diseases, current clinical repair strategies include corneal lesion debridement, conjunctival flap coverage, amniotic membrane transplantation, corneal transplantation, contact lens application, and injectable sealants. Injectable hydrogels, as smart materials that transition from a liquid precursor to a solid gel in response to external stimuli (e.g., light, temperature, or chemical cross-linking), enable precise filling of corneal defects via minimally invasive injection. They offer superior morphological adaptability, conforming tightly to irregular wound surfaces and achieving sutureless closure. Moreover, they promote regenerative repair of the epithelium, stroma, and nerves, significantly reducing patient discomfort, infection risk, recovery time, and healthcare costs, thereby advancing the paradigm of corneal repair from "transplant substitution" to "in situ regeneration."
- Conditions
- Corenal Diseases
- Being tested
- Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sutureless Ophthalmic Hydrogel for Corneal Stromal DefectsBiological
Surgery was performed under peribulbar block anesthesia. After excision of the corneal lesion, the surface moisture of the recipient bed was dried with a sponge, and a cotton pad was placed over the pupillary area to protect the fundus. The hydrogel was pre-liquefied in a 37 °C water bath, then instilled into the lamellar defect using a sterile syringe, followed by irradiation with a 365 nm light source at an intensity of 18 mW/cm² for 30 seconds to achieve curing. A bandage contact lens could be applied.
| Study group | Role | What they receive |
|---|---|---|
| Sutureless Ophthalmic Hydrogel for Repairing Corneal Stromal Defects | Experimental | Not described Receives: Biological: Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ocular Adverse Events and Hydrogel-Related Ocular Complications (Irritation, Displacement, Infection, Corneal Cell/Epithelial Changes)
Description: Assess ocular safety outcomes including:
- Ocular surface irritation symptoms (eye redness, foreign body sensation, tearing, photophobia, etc.)
- Hydrogel adhesion status (presence or absence of hydrogel displacement or detachment)
- Corneal infection
- Corneal endothelial cell morphology and density changes
- Corneal epithelial healing time The incidence and severity of all events will be recorded.
Measured: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Secondary outcomes (3)
Corneal Clarity Full Rating Scale (0-4 points full-scale assessment for corneal transparency after hydrogel repair)
Observe the transparency of the cornea in the hydrogel transplantation area using a slit lamp examination, score it, and record the corneal transparency scores at different follow-up time points.
Full scale information: Minimum score = 0, Maximum score = 4; higher scores indicate worse corneal opacity/poorer corneal clarity, lower scores indicate better corneal transparency.
Scoring criteria:
0 = completely transparent;
- = slight opacity, not easily detectable under direct illumination;
- = mild opacity, visible under slit lamp;
- = moderate opacity, partially obscuring the iris;
- = severe opacity, obscuring details of intraocular structures.
Measured: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Change in corneal thickness (OCT measurement, µm)
Use corneal OCT to observe changes in corneal thickness in the hydrogel transplantation area, and record the residual corneal thickness, hydrogel thickness, and total corneal thickness at different follow-up time points.
Measured: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Change in visual acuity (decimal chart)
Use a decimal visual acuity chart to record the visual acuity and best corrected visual acuity at different follow-up time points, and evaluate the recovery and changes in visual acuity
Measured: 1st day preoperatively, 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Sep 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 Corenal DiseasesStudies 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
- 30 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
- NCT07638215
- Sponsor's protocol ID
- SDSYKYY202510-2
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2026
- Last updated
- 8 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 8 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 Sutureless Ophthalmic Hydrogel for Corneal Wound Repair
- ClinicalTrials.gov ID
- NCT07638215
- Acronym / sponsor ID
- SDSYKYY202510-2
- Conditions
- Corenal Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suxia LiUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Jun 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.
Corneal blindness is one of the leading causes of blindness worldwide. For various infectious and non-infectious corneal diseases, current clinical repair strategies include corneal lesion debridement, conjunctival flap coverage, amniotic membrane transplantation, corneal transplantation, contact lens application, and injectable sealants. Injectable hydrogels, as smart materials that transition from a liquid precursor to a solid gel in response to external stimuli (e.g., light, temperature, or chemical cross-linking), enable precise filling of corneal defects via minimally invasive injection. They offer superior morphological adaptability, conforming tightly to irregular wound surfaces and achieving sutureless closure. Moreover, they promote regenerative repair of the epithelium, stroma, and nerves, significantly reducing patient discomfort, infection risk, recovery time, and healthcare costs, thereby advancing the paradigm of corneal repair from "transplant substitution" to "in situ regeneration."
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sutureless Ophthalmic Hydrogel for Repairing Corneal Stromal Defects | Experimental | Biological: Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- You must meet all the following inclusion criteria to participate in the study:
Key exclusion criteria (11 listed)
- You will be excluded from the study if you meet any of the following exclusion criteria:
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 |
|---|---|---|
| Sutureless Ophthalmic Hydrogel for Corneal Stromal DefectsSurgery was performed under peribulbar block anesthesia. After excision of the corneal lesion, the surface moisture of the recipient bed was dried with a sponge, and a cotton pad was placed over the pupillary area to protect the fundus. The hydrogel was pre-liquefied in a 37 °C water bath, then instilled into the lamellar defect using a sterile syringe, followed by irradiation with a 365 nm light source at an intensity of 18 mW/cm² for 30 seconds to achieve curing. A bandage contact lens could be applied. | Biological | Sutureless Ophthalmic Hydrogel for Repairing Corneal Stromal Defects |
Primary outcome
Incidence of Ocular Adverse Events and Hydrogel-Related Ocular Complications (Irritation, Displacement, Infection, Corneal Cell/Epithelial Changes)
Time frame: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Description: Assess ocular safety outcomes including: * Ocular surface irritation symptoms (eye redness, foreign body sensation, tearing, photophobia, etc.) * Hydrogel adhesion status (presence or absence of hydrogel displacement or detachment) * Corneal infection * Corneal endothelial cell morphology and density changes * Corneal epithelial healing time The incidence and severity of all events will be recorded.
3 secondary outcomes
Corneal Clarity Full Rating Scale (0-4 points full-scale assessment for corneal transparency after hydrogel repair)
Time frame: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Change in corneal thickness (OCT measurement, µm)
Time frame: 1st day, 1st week, 2nd week, 1st month and 2nd month postoperatively
Change in visual acuity (decimal chart)
Time frame: 1st day preoperatively, 1st day, 1st week, 2nd week, 1st month and 2nd 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 8 Oct 2026.
- Individual participant dataSharing planned: Yes
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 Sutureless Ophthalmic Hydrogel for Corneal Stromal Defects in people with Corenal Diseases, 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 11 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 8 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 Li (+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?
Incidence of Ocular Adverse Events and Hydrogel-Related Ocular Complications (Irritation, Displacement, Infection, Corneal Cell/Epithelial Changes) (time frame: 1st day, 1st week, 2nd week, 1st month and 2nd 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 8 Oct 2026.