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ACTIVE NOT RECRUITING
NCT04465409
NA

Evaluation of Safety and Efficacy of Intrastromal Implantation of CorVision® Bioengineered Corneal Inlay for Correction of Presbyopia.

Sponsor: LinkoCare Life Sciences AB

View on ClinicalTrials.gov

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

DEVICE

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