KeratoprosthesisNCT07526389
Evaluation of the Efficacy and Safety of Aspheric Keratoprosthesis in the Treatment of Patients With Corneal Blindness: A Clinical Study
A study testing Investigational Keratoprosthesis Implantation in people with Keratoprosthesis and Corneal Blindness, run by Shanghai Vision Science Engineer Medical Equipment Co., Ltd.
Trial summary
This is a prospective, multicenter, randomized controlled (1:1) non-inferiority clinical trial. A total of 54 subjects are scheduled to be enrolled at no fewer than 2 study sites in China. After providing written informed consent, all subjects will undergo screening assessments. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Keratoprosthesis, Corneal Blindness
- What is being tested?
- Investigational Keratoprosthesis Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years (inclusive), gender unrestricted;
- Patients with corneal blindness, unable to perform activities of daily living independently, and best-corrected visual acuity < 0.05 in both eyes;
- Patients with a high expected risk of failure of allogeneic corneal transplantation or high surgical risk for corneal transplantation;
- Relatively stable primary ocular diseases, no active purulent infection, and general condition sufficient to tolerate surgery;
- Normal intraocular pressure, or stable intraocular pressure after treatment for glaucoma (IOP < 21 mmHg);
- Normal structure and function of the retina and optic nerve, with preserved visual potential;
- Willing to participate in this study and have signed the written informed consent form.
Who cannot join
- Patients with poorly controlled intraocular pressure or requiring IOP-lowering medication, assessed as ineligible for surgery.
- Patients with active conjunctival infection in the affected eye, assessed as unable to tolerate surgery.
- Patients with unhealed wound following allogeneic penetrating keratoplasty.
- Patients with anatomical abnormalities such as eyelid atresia or requiring a prosthetic device to penetrate the skin.
- Patients with severely impaired retinal or optic nerve function with no potential for visual improvement.
- Patients with a history of malignant tumor in or around the eye, judged ineligible by the investigator.
Show all 14Show fewer
- Patients with intolerance to local anesthetics, mydriatics, or device components, judged ineligible by the investigator.
- Patients with severe diseases of major organs including heart, liver, and kidney, judged ineligible by the investigator.
- Patients with severe coagulation disorders, judged ineligible by the investigator.
- Patients with absolute glaucoma, judged ineligible by the investigator.
- Patients with severe systemic diseases and a life expectancy of < 2 years.
- Pregnant or lactating females.
- Patients who do not understand the risks of keratoprosthesis surgery, cannot comply with regular follow-up, or fail to administer medication as required.
- Other patients considered ineligible for this clinical trial by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yifei Zhang Shanghai Vision Science Engineer Medical Equipment Co., Ltd, Project Manager contact
About this study
This is a prospective, multicenter, randomized controlled (1:1) non-inferiority clinical trial. A total of 54 subjects are scheduled to be enrolled at no fewer than 2 study sites in China.
After providing written informed consent, all subjects will undergo screening assessments. Those who fully meet all inclusion criteria and satisfy none of the exclusion criteria will be enrolled in this clinical trial.
- Conditions
- Keratoprosthesis, Corneal Blindness
- Being tested
- Investigational Keratoprosthesis Implantation, Control Medical Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Keratoprosthesis ImplantationDevice
Screen eligible patients who meet all inclusion criteria, complete randomization, and implant the investigational device per the randomization assignment. All surgical procedures must be performed in strict accordance with the clinical trial protocol and the product's instructions for use. Postoperative follow-up visits and relevant examinations shall be completed in full compliance with protocol requirements.
Control Medical DeviceDevice
This study adopts a randomized controlled design. Following provision of written informed consent, participants will complete the screening assessments. Eligible subjects meeting all inclusion criteria and satisfying none of the exclusion criteria will be randomized in a 1:1 ratio to either the investigational group or the control group.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients meeting the eligibility criteria will be randomized. Those randomized to the investigational group will be treated with the investigational device. Receives: Device: Investigational Keratoprosthesis Implantation |
| Control Group | Active comparator | Patients meeting the eligibility criteria will be randomized. Those randomized to the control group will receive the control device. Receives: Device: Control Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation.
To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation.
Measured: 6 months postoperatively
Secondary outcomes (3)
Best Corrected Visual Acuity (BCVA)
Best Corrected Visual Acuity (BCVA)
Measured: Follow-up at 1, 3, 6, and 12 months after Stage II surgery
Uncorrected Visual Acuity (UCVA)
Uncorrected Visual Acuity (UCVA)
Measured: Follow-up at 1, 3, 6, and 12 months after Stage II surgery
Blindness Resolution Rate
Blindness Resolution Rate
Measured: Follow-up at 1, 3 and 12 months after Stage II surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoprosthesisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Vision Science Engineer Medical Equipment Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526389
- Sponsor's protocol ID
- VSE-KP-001
- Other IDs
- Company
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Aspheric Keratoprosthesis in the Treatment of Patients With Corneal Blindness: A Clinical Study
- ClinicalTrials.gov ID
- NCT07526389
- Acronym / sponsor ID
- VSE-KP-001
- Conditions
- Keratoprosthesis, Corneal Blindness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai Vision Science Engineer Medical Equipment Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Apr 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.
This is a prospective, multicenter, randomized controlled (1:1) non-inferiority clinical trial. A total of 54 subjects are scheduled to be enrolled at no fewer than 2 study sites in China.
After providing written informed consent, all subjects will undergo screening assessments. Those who fully meet all inclusion criteria and satisfy none of the exclusion criteria will be enrolled in this clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Investigational Keratoprosthesis ImplantationPatients meeting the eligibility criteria will be randomized. Those randomized to the investigational group will be treated with the investigational device. |
| Control Group | Active comparator | Device: Control Medical DevicePatients meeting the eligibility criteria will be randomized. Those randomized to the control group will receive the control device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years (inclusive), gender unrestricted;
- Patients with corneal blindness, unable to perform activities of daily living independently, and best-corrected visual acuity < 0.05 in both eyes;
- Patients with a high expected risk of failure of allogeneic corneal transplantation or high surgical risk for corneal transplantation;
- Relatively stable primary ocular diseases, no active purulent infection, and general condition sufficient to tolerate surgery;
- Normal intraocular pressure, or stable intraocular pressure after treatment for glaucoma (IOP < 21 mmHg);
Key exclusion criteria (14 listed)
- Patients with poorly controlled intraocular pressure or requiring IOP-lowering medication, assessed as ineligible for surgery.
- Patients with active conjunctival infection in the affected eye, assessed as unable to tolerate surgery.
- Patients with unhealed wound following allogeneic penetrating keratoplasty.
- Patients with anatomical abnormalities such as eyelid atresia or requiring a prosthetic device to penetrate the skin.
- Patients with severely impaired retinal or optic nerve function with no potential for visual improvement.
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 |
|---|---|---|
| Investigational Keratoprosthesis ImplantationScreen eligible patients who meet all inclusion criteria, complete randomization, and implant the investigational device per the randomization assignment. All surgical procedures must be performed in strict accordance with the clinical trial protocol and the product's instructions for use. Postoperative follow-up visits and relevant examinations shall be completed in full compliance with protocol requirements. | Device | Study Group |
| Control Medical DeviceThis study adopts a randomized controlled design. Following provision of written informed consent, participants will complete the screening assessments. Eligible subjects meeting all inclusion criteria and satisfying none of the exclusion criteria will be randomized in a 1:1 ratio to either the investigational group or the control group. | Device | Control Group |
Primary outcome
To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation.
Time frame: 6 months postoperatively
To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation.
3 secondary outcomes
Best Corrected Visual Acuity (BCVA)
Time frame: Follow-up at 1, 3, 6, and 12 months after Stage II surgery
Uncorrected Visual Acuity (UCVA)
Time frame: Follow-up at 1, 3, 6, and 12 months after Stage II surgery
Blindness Resolution Rate
Time frame: Follow-up at 1, 3 and 12 months after Stage II surgery
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 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Keratoprosthesis
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
Not yet recruitingPhase 1
Subconjunctival Humira for Boston Keratoprosthesis
Penetrating Keratoplasty, Multiple Graft Failure
Recruiting
Corneal Collagen Crosslinking to Increase the Resistance of the Support Graft of the KPro Type I Against Corneal Melting
Corneal Melting in Boston Keratoprosthesis Type I
Recruiting
The Role of Transscleral Cyclophotocoagulation in Patients Undergoing a Boston Keratoprosthesis
Glaucoma, Eye Diseases
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.
Yifei Zhang Shanghai Vision Science Engineer Medical Equipment Co., Ltd, Project Manager contact
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Keratoprosthesis Implantation in people with Keratoprosthesis and Corneal Blindness, run by Shanghai Vision Science Engineer Medical Equipment Co., Ltd.
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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yifei Zhang Shanghai Vision Science Engineer Medical Equipment Co., Ltd, Project Manager (+86 139 6215 2809, VSE-QA@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation. (time frame: 6 months 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 13 Apr 2026.