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Evaluation of Safety and Efficacy of Intrastromal Implantation of CorVision® Bioengineered Corneal Inlay for Correction of Presbyopia.
Sponsor: LinkoCare Life Sciences AB
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.
Key Details
Gender
All
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2020-03-25
Completion Date
2026-06-30
Last Updated
2025-09-03
Healthy Volunteers
Yes
Conditions
Interventions
Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia.
Presbyopia is an age-related progressive loss of crystalline lens accommodation power resulting in the decreased ability to see near objects. CorVision® is a tissue-mimetic device primarily intended to be used as a corneal inlay in the management of presbyopia and low hypermetropia. The inlay is inserted into the patient's cornea via a minimally invasive laser pocket procedure to modify corneal surface topography and corneal optical performance.
Locations (1)
Gemini Eye Clinics
Zlín, Czechia