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.

NCT Number	NCT07526389
Lead Sponsor	Shanghai Vision Science Engineer Medical Equipment Co., Ltd
Conditions	Keratoprosthesis, Corneal Blindness
Enrollment	54 participants
Start Date	2026-04-01
Primary Completion	2027-12-30 (estimated)
Study Completion	2027-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-13