Evaluation of the Efficacy and Safety of Aspheric Keratoprosthesis in the Treatment of Patients W… (NCT07526389) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Efficacy and Safety of Aspheric Keratoprosthesis in the Treatment of Patients With Corneal Blindness: A Clinical Study
54 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to 80 years (inclusive), gender unrestricted;
. Patients with corneal blindness, unable to perform activities of daily living independently, and best-corrected visual acuity \< 0.05 in both eyes;
. Patients with a high expected risk of failure of allogeneic corneal transplantation or high surgical risk for corneal transplantation;
. Relatively stable primary ocular diseases, no active purulent infection, and general condition sufficient to tolerate surgery;
. Normal intraocular pressure, or stable intraocular pressure after treatment for glaucoma (IOP \< 21 mmHg);
. Normal structure and function of the retina and optic nerve, with preserved visual potential;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the blindness recovery rate at 6 months postoperatively in patients with severe corneal blindness who underwent keratoprosthesis implantation.
Timeframe: 6 months postoperatively
Trial details
NCT IDNCT07526389
SponsorShanghai Vision Science Engineer Medical Equipment Co., Ltd