PresbyopiaCorVision4yFUNCT07623720
CorVision® 4-year Follow-up
An observational study of Presbyopia, run by Gemini Eye Clinic at 1 site in Czechia.
Trial summary
The objective of the study is to assess the long-term safety and effectiveness of the CorVision® microlens implanted in presbyopic patients for the management of management of presbyopia and near vision impairment. Approximately 100 patients in the Czech Republic will participate in this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Presbyopia
- How many people
- 95 participants
- Where
- 1 siteCzechia
- Study dates
- 27 Jun 2025to 25 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target population are patients who suffered from presbyopia and underwent the original CorVision clinical study are medically suitable to undertake the current clinical study investigation.
Who may be able to join
- Subjects must have undergone implantation of CorVision microlens under study protocol CMG-PRT-002.
- Provide informed consent
- Willing to participate in the ophthalmological examinations
Who cannot join
- Patients with severe ocular or general disorders that would prevent them from completed the visit.
- Patients not being able to understand and give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four Years Extended Follow-Up on CorVision® Bioengineered Corneal Microlens: Safety and Efficacy
The objective of the study is to assess the long-term safety and effectiveness of the CorVision® microlens implanted in presbyopic patients for the management of management of presbyopia and near vision impairment. Approximately 100 patients in the Czech Republic will participate in this study. The study was reviewed and approved by an independent research ethics committee and also by the State Institute for Drug Control (SÚKL). The study will consist of a single visit during which standard, non-invasive, and painless examinations will be performed. This visit will correspond to the 4-year follow-up visit of the original clinical trial.
- Conditions
- Presbyopia
- Keywords
- microlens, presbyopia, eye surgery, CorVision
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-presbyopia correction with unilaterally implanted microlens | Presbyopic patients who have undergone implantation of the CorVision microlens according to study protocol CMG-PRT-002. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Near Visual Acuity of 0.3 logMAR or better
More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively.
Measured: At least 4 years after the implantation
Implant removal
The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes.
Measured: At least 4 years after the implantation
Secondary outcomes (1)
Clinically significant corneal haze occurrence
Clinically significant corneal haze is defined as any new stromal clouding in or near the laser-created pocket that leads to a reduction in central corneal clarity/transparency, is visible upon slit-lamp examination, and is graded as ≥ 2 on a standardized corneal haze grading scale.
Measured: At least 4 years after the implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start27 Jun 2025
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gemini Eye Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Katerina Klimesova, Gemini Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623720
- Sponsor's protocol ID
- CMG-PRT-002-1
- Acronym
- CorVision4yFU
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 3 Jun 2026
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Years Extended Follow-Up on CorVision® Bioengineered Corneal Microlens: Safety and Efficacy
- ClinicalTrials.gov ID
- NCT07623720
- Acronym / sponsor ID
- CorVision4yFU / CMG-PRT-002-1
- Conditions
- Presbyopia
- Keywords
- microlens, presbyopia, eye surgery, CorVision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Gemini Eye ClinicIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 3 Jun 2026 (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.
The objective of the study is to assess the long-term safety and effectiveness of the CorVision® microlens implanted in presbyopic patients for the management of management of presbyopia and near vision impairment. Approximately 100 patients in the Czech Republic will participate in this study. The study was reviewed and approved by an independent research ethics committee and also by the State Institute for Drug Control (SÚKL). The study will consist of a single visit during which standard, non-invasive, and painless examinations will be performed. This visit will correspond to the 4-year follow-up visit of the original clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-presbyopia correction with unilaterally implanted microlens | – | –Presbyopic patients who have undergone implantation of the CorVision microlens according to study protocol CMG-PRT-002. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population are patients who suffered from presbyopia and underwent the original CorVision clinical study are medically suitable to undertake the current clinical study investigation.
Key inclusion criteria (3 listed)
- Subjects must have undergone implantation of CorVision microlens under study protocol CMG-PRT-002.
- Provide informed consent
- Willing to participate in the ophthalmological examinations
Key exclusion criteria (2 listed)
- Patients with severe ocular or general disorders that would prevent them from completed the visit.
- Patients not being able to understand and give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Uncorrected Near Visual Acuity of 0.3 logMAR or better
Time frame: At least 4 years after the implantation
More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively.
Implant removal
Time frame: At least 4 years after the implantation
The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes.
1 secondary outcome
Clinically significant corneal haze occurrence
Time frame: At least 4 years after the implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- the protocol of the original study - ClinicalTrials.gov ID: NCT04465409Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia, run by Gemini Eye Clinic 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 3 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Uncorrected Near Visual Acuity of 0.3 logMAR or better (time frame: At least 4 years after the implantation). 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 Jun 2026.