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

NCT04465409 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-09-03

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • LinkoCare Life Sciences AB

    lead INDUSTRY

Principal Investigators

  • Katerina Klimesova, MD · Gemini Eye Clinics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-25
Primary Completion
2022-09-25
Completion
2026-06-30

Countries

  • Czechia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04465409 on ClinicalTrials.gov