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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
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.
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.
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.
Time frame: 6 months postoperatively
Best Corrected Visual Acuity (BCVA)
Best Corrected Visual Acuity (BCVA)
Time frame: Follow-up at 1, 3, 6, and 12 months after Stage II surgery
Uncorrected Visual Acuity (UCVA)
Uncorrected Visual Acuity (UCVA)
Time frame: Follow-up at 1, 3, 6, and 12 months after Stage II surgery
Blindness Resolution Rate
Blindness Resolution Rate
Time frame: Follow-up at 1, 3 and 12 months after Stage II surgery
Yifei Zhang Shanghai Vision Science Engineer Medical Equipment Co., Ltd, Project Manager
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