Evaluation of Safety and Efficacy of Intrastromal Implantation of CorVision® Bioengineered Cornea… (NCT04465409) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Safety and Efficacy of Intrastromal Implantation of CorVision® Bioengineered Corneal Inlay for Correction of Presbyopia.
Czechia110 participantsStarted 2020-03-25
Plain-language summary
This clinical investigation is a prospective, multicentre, non-comparative case series to assess safety and efficacy of CorVision® bioengineered corneal inlay for improving uncorrected near vision in presbyopic subjects.
In this study a sterile medical grade collagen-based bioengineered corneal inlay (CorVision®), which closely mimics the human corneal tissue, will be tested as a natural microlens for correction of near vision in presbyopic patients. The primary endpoint for this study is to further determine the safety of the inlay and the secondary endpoint is to determine the efficacy of the inlay to improve uncorrected near vision.
CorVision® implantation will be done via a minimally invasive laser-assisted intra-stromal surgery. Besides important information concerning details of the surgical method and postoperative care, tolerance of the device and possible adverse events will be reported along with several clinical parameters to be measured preoperatively and postoperatively. The study will consist of 110 subjects receiving the inlay to be included within a recruitment period of 18 months at multiple clinical sites. All subjects will be followed for minimum 12-months postoperatively. Postoperative evaluations are scheduled at 1 week, 1, 3, 6, and 12 months.
Who can participate
Age range
40 Years – 65 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:
* Signed and dated informed consent
* Presbyopic adults, Male or female between 40-65 years of age who need from +1.25 D to +3.50 D of reading addition in the non- dominant eye to improve near visual acuity by at least one line or more.
* Manifest refraction spherical equivalent (MRSE) between -0.75 and +1.50 D with ≤1.5 D of refractive cylinder in the non-dominant eye.
* Stable refraction, i.e. MSRE within 0.50 D over prior 12 months in the non-dominant eye.
* Corrected distance visual acuity CDVA ≥ 0.7 in the dominant and non-dominant eye
Exclusion Criteria:
* Anterior segment pathology in the non-dominant eye.
* Signs or symptoms of clinically significant cataracts in the non-dominant eye.
* Residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormality (including endothelial dystrophy, recurrent corneal erosion, etc.) in the nondominant eye.
* Visually significant macular pathology
* Central corneal thickness \<470 microns in either eye and corneal curvature ≥ 50D
* Corneal ectasia, keratoconus or form frust keratoconus
* Clinically significant dry eye disease
* Any prior ocular surgery in the non-dominant eye.
* History of herpes zoster or herpes simplex keratitis in the non-dominant eye.
* Inability of patient to understand the study procedures and thus inability to give informed consent.
* Participation in another clinical study within the last 3 months
* Already included once in this study (can only be included for…
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.
1This trial is listed as 'active, not recruiting' — does that mean there's any chance of joining it now, or should we be looking at other options for my presbyopia treatment?
2The trial phase is listed as 'NA,' which I understand may mean it's a first-in-human or exploratory study — what does that tell us about how much is already known about the safety of this corneal inlay compared to established presbyopia treatments like reading glasses, contact lenses, or LASIK?
3The study involves surgically implanting a bioengineered inlay inside the cornea — what are the potential risks if the implant doesn't work as hoped, and can it be safely removed or reversed?
4Since the trial is measuring both safety and efficacy as its primary outcomes, does that suggest we don't yet have strong evidence that this device works better than what's already available for presbyopia?
5Are there proven, non-surgical treatments for my presbyopia that my doctor would recommend considering first, before exploring an investigational surgical implant like this one?
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.