Evaluation of the Efficacy and Safety of Aspheric Keratoprosthesis in the Treatment of Patients With Corneal Blindness: A Clinical 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Corneal Blindness; Keratoprosthesis
• Intervention / Treatment: Device: Investigational Keratoprosthesis Implantation; Device: Control Medical Device

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yifei Zhang Shanghai Vision Science Engineer Medical Equipment Co., Ltd, Project Manager; Phone Number: +86 139 6215 2809; Email: VSE-QA@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 to 80 years (inclusive), gender unrestricted;
2. Patients with corneal blindness, unable to perform activities of daily living independently, and best-corrected visual acuity < 0.05 in both eyes;
3. Patients with a high expected risk of failure of allogeneic corneal transplantation or high surgical risk for corneal transplantation;
4. Relatively stable primary ocular diseases, no active purulent infection, and general condition sufficient to tolerate surgery;
5. Normal intraocular pressure, or stable intraocular pressure after treatment for glaucoma (IOP < 21 mmHg);
6. Normal structure and function of the retina and optic nerve, with preserved visual potential;
7. Willing to participate in this study and have signed the written informed consent form.

Exclusion Criteria:

1. Patients with poorly controlled intraocular pressure or requiring IOP-lowering medication, assessed as ineligible for surgery.
2. Patients with active conjunctival infection in the affected eye, assessed as unable to tolerate surgery.
3. Patients with unhealed wound following allogeneic penetrating keratoplasty.
4. Patients with anatomical abnormalities such as eyelid atresia or requiring a prosthetic device to penetrate the skin.
5. Patients with severely impaired retinal or optic nerve function with no potential for visual improvement.
6. Patients with a history of malignant tumor in or around the eye, judged ineligible by the investigator.
7. Patients with intolerance to local anesthetics, mydriatics, or device components, judged ineligible by the investigator.
8. Patients with severe diseases of major organs including heart, liver, and kidney, judged ineligible by the investigator.
9. Patients with severe coagulation disorders, judged ineligible by the investigator.
10. Patients with absolute glaucoma, judged ineligible by the investigator.
11. Patients with severe systemic diseases and a life expectancy of < 2 years.
12. Pregnant or lactating females.
13. Patients who do not understand the risks of keratoprosthesis surgery, cannot comply with regular follow-up, or fail to administer medication as required.
14. Other patients considered ineligible for this clinical trial by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Patients meeting the eligibility criteria will be randomized. Those randomized to the investigational group will be treated with the investigational device.	Device: Investigational Keratoprosthesis Implantation; 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.
Active Comparator: Control Group; Patients meeting the eligibility criteria will be randomized. Those randomized to the control group will receive the control device.	Device: Control Medical Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity (BCVA)	Best Corrected Visual Acuity (BCVA)	Follow-up at 1, 3, 6, and 12 months after Stage II surgery
Uncorrected Visual Acuity (UCVA)	Uncorrected Visual Acuity (UCVA)	Follow-up at 1, 3, 6, and 12 months after Stage II surgery
Blindness Resolution Rate	Blindness Resolution Rate	Follow-up at 1, 3 and 12 months after Stage II surgery

Collaborators and Investigators

• Sponsor: Shanghai Vision Science Engineer Medical Equipment Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: VSE-KP-001; Company (Other Grant/Funding Number: Shanghai Vision Science Engineer Medical Equipment Co., Ltd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No