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 range18 Years â 80 Years
SexALL
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Inclusion criteria
â. Age 18 to 80 years (inclusive), gender unrestricted;
â. Patients with corneal blindness, unable to perform activities of daily living independently, and best-corrected visual acuity \< 0.05 in both eyes;
â. Patients with a high expected risk of failure of allogeneic corneal transplantation or high surgical risk for corneal transplantation;
â. Relatively stable primary ocular diseases, no active purulent infection, and general condition sufficient to tolerate surgery;
â. Normal intraocular pressure, or stable intraocular pressure after treatment for glaucoma (IOP \< 21 mmHg);
â. Normal structure and function of the retina and optic nerve, with preserved visual potential;
â. Willing to participate in this study and have signed the written informed consent form.
Exclusion criteria
â. Patients with poorly controlled intraocular pressure or requiring IOP-lowering medication, assessed as ineligible for surgery.
â. Patients with active conjunctival infection in the affected eye, assessed as unable to tolerate surgery.
â. Patients with unhealed wound following allogeneic penetrating keratoplasty.
â. Patients with anatomical abnormalities such as eyelid atresia or requiring a prosthetic device to penetrate the skin.
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