PresbyopiaCorVisionNCT04465409
Evaluation of Safety and Efficacy of Intrastromal Implantation of CorVision® Bioengineered Corneal Inlay for Correction of Presbyopia.
A study testing Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia. in people with Presbyopia, run by LinkoCare Life Sciences AB at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Mar 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Presbyopia
- Being tested
- Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia.
- Keywords
- presbyopia, bioengineered corneal inlay, femto second laser, intrastromal implantation, biocompatible, medical device, sterile, medical grade, natural, refractive error
- Medical subject headings
- Presbyopia, Infertility, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Presbyopic adults | Experimental | 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. Receives: Device: Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome
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.
Measured: 6 months
Efficacy outcome
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start25 Mar 2020
- Primary completion25 Sep 2022
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- LinkoCare Life Sciences AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katerina Klimesova, MD, Principal investigator, Gemini Eye Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465409
- Sponsor's protocol ID
- CMG-PRT-002-Rev6
- Acronym
- CorVision
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2020
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Intrastromal Implantation of CorVision® Bioengineered Corneal Inlay for Correction of Presbyopia.
- ClinicalTrials.gov ID
- NCT04465409
- Acronym / sponsor ID
- CorVision / CMG-PRT-002-Rev6
- Conditions
- Presbyopia
- Keywords
- presbyopia, bioengineered corneal inlay, femto second laser, intrastromal implantation, biocompatible, medical device, sterile, medical grade
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- LinkoCare Life Sciences ABIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Presbyopic adults | Experimental | Device: Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia.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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Presbyopic adults |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katerina Klimesova, MD principal investigator
Gemini Eye Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia. in people with Presbyopia, run by LinkoCare Life Sciences AB at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.