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

September 2, 2025 updated by: LinkoCare Life Sciences AB

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Upon signing of informed consent and study inclusion, both eyes will be screened to determine which eye is dominant and to ensure that the non-dominant eye meets the visual acuity, refraction, and other inclusion criteria. In this investigation, the monovision concept will be utilized, e.g. CorVision® will be implanted in the non-dominant eye to improve near vision and the dominant eye is left intact or corrected by a standard refractive surgery to emmetropia. In brief, subjects will undergo laser corneal surgery on their non-dominant eye to create an anterior stromal pocket into which the investigational device will be implanted. Combined antibiotic - steroid eye drops will be instilled for 4 weeks post-implantation.

The investigational treatment does not introduce foreign cells into the patient, requires only a short course of local immunosuppression (4 weeks compared to 12 months or longer for some other treatment options), and is reversible as the investigational device can be removed later if required. Moreover, should serious intra-operative or post-operative complications arise during or following implantation of the investigational device that cannot be treated with medications (for example thinning or clouding of the cornea), the CorVision® device can be removed and the patient can undergo standard-of-care for complications after laser surgery.

Following implantation of the CorVision®, postoperative eye examinations will be conducted at 1 week, 1 month, then at month 3, 6, and 12 and outside of these standard examination times on an as-needed basis at any time. Examinations will include corneal tomography, central corneal thickness, slit lamp corneal transparency, keratometry, anterior segment optical coherence tomography, and general ophthalmic examination including tear break up time, refraction, uncorrected and corrected distance, intermediate and near visual acuity, and in some eyes aberrometer measurements, defocus curve or contrast sensitivity.

The proof-of-concept and feasibility to implant CorVision® by standard surgical methods such as a femto-second assisted pocket surgery and postoperative treatment and assessment protocol for this new medical device have already been developed via prior pre-clinical evaluations and some pilot clinical studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Czechia
      • Zlín, Czechia, 760 01
        • Gemini Eye Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 one treated eye).
  • General history judged by the investigator to be incompatible with the study (e.g., life-
  • threatening patient condition, other condition where postoperative follow-up may be difficult).
  • known uncontrolled diabetes or other neuro-degenerative disorder (as corneal nerves can be affected leading to impaired wound healing)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Presbyopic adults

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.

In this investigation, CorVision® will be implanted in the non-dominant eye to improve near vision and the dominant eye is left intact or corrected by a standard refractive surgery to emmetropia. In brief, subjects will undergo laser corneal surgery on their non-dominant eye to create an anterior stromal pocket into which the investigational device will be implanted.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety outcome
Time Frame: 6 months
The primary safety endpoint is defined such that a rejection leading to implant removal should occur in no more than 3% of implanted eyes. The implant rejection is defined as a clinical situation when the implanted eye has decreased central corneal clarity and decreased implant clarity, corneal vascularization inside of laser created pocket and inflammation.
6 months
Efficacy outcome
Time Frame: 6 months
The primary efficacy endpoint is that more than 65% of the eyes should have an uncorrected near visual acuity (UNVA) of 0.3 logMAR or better at 6 months postoperatively.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LinkoCare Life Sciences AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katerina Klimesova, MD, Gemini Eye Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMG-PRT-002-Rev6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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