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Not yet recruiting NCT07526389

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

No phase Interventional Keratoprosthesis Corneal Blindness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Investigational Keratoprosthesis Implantation, Control Medical Device.
Who it may be relevant to
Registry conditions: Keratoprosthesis, Corneal Blindness. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Best Corrected Visual Acuity (BCVA) [Time frame: Follow-up at 1, 3, 6, and 12 months after Stage II surgery]
  • Uncorrected Visual Acuity (UCVA) [Time frame: Follow-up at 1, 3, 6, and 12 months after Stage II surgery]
  • Blindness Resolution Rate [Time frame: Follow-up at 1, 3 and 12 months after Stage II surgery]

Eligibility criteria

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;
  • Willing to participate in this study and have signed the written informed consent form.

Exclusion criteria

  • Patients with poorly controlled intraocular pressure or requiring IOP-lowering medication, assessed as ineligible for surgery.
  • Patients with active conjunctival infection in the affected eye, assessed as unable to tolerate surgery.
  • Patients with unhealed wound following allogeneic penetrating keratoplasty.
  • Patients with anatomical abnormalities such as eyelid atresia or requiring a prosthetic device to penetrate the skin.
  • Patients with severely impaired retinal or optic nerve function with no potential for visual improvement.
  • Patients with a history of malignant tumor in or around the eye, judged ineligible by the investigator.
  • Patients with intolerance to local anesthetics, mydriatics, or device components, judged ineligible by the investigator.
  • Patients with severe diseases of major organs including heart, liver, and kidney, judged ineligible by the investigator.
  • Patients with severe coagulation disorders, judged ineligible by the investigator.
  • Patients with absolute glaucoma, judged ineligible by the investigator.
  • Patients with severe systemic diseases and a life expectancy of < 2 years.
  • Pregnant or lactating females.
  • Patients who do not understand the risks of keratoprosthesis surgery, cannot comply with regular follow-up, or fail to administer medication as required.
  • Other patients considered ineligible for this clinical trial by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07526389 · VSE-KP-001 · Company

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗