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| ID | Type | Description | Link |
|---|---|---|---|
| Company | Other Grant/Funding Number | Shanghai Vision Science Engineer Medical Equipment Co., Ltd |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Patients meeting the eligibility criteria will be randomized. Those randomized to the investigational group will be treated with the investigational device. |
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| Control Group | Active Comparator | Patients meeting the eligibility criteria will be randomized. Those randomized to the control group will receive the control device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Keratoprosthesis Implantation | Device | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifei Zhang Shanghai Vision Science Engineer Medical Equipment Co., Ltd, Project Manager | Contact | +86 139 6215 2809 | VSE-QA@hotmail.com |
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| Control Medical Device | 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. |
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| 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 |