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

NCT07526389 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-13

No results posted yet for this study

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. 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

Interventions

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.

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.

Sponsors & Collaborators

  • Shanghai Vision Science Engineer Medical Equipment Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-30
Completion
2027-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07526389 on ClinicalTrials.gov