Presbyopia CorrectionVIS Opti-K 002NCT06702020
VIS Opti-K Vision Improvement for Presbyopes
An observational study of Presbyopia Correction, run by VIS, Inc..
Trial summary
The VIS Opti-K device and procedure were used to provide vision improvement to patients with presbyopia. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Presbyopia Correction
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 13 Mar 2007to 31 Jul 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients had documented presbyopia and a need for near vision improvement
Who may be able to join
- Female or male Any race 40 years of age or older Presbyopia
Who cannot join
- None
- -
About this study
The VIS Opti-K device and procedure were used to provide vision improvement to patients with presbyopia.
Read the detailed description
The VIS Opti-K device was used to irradiate the cornea with light that changed corneal shape.
- Conditions
- Presbyopia Correction
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected distance and near visual acuities
Uncorrected distance and near visual acuities are measured using ETDRS or similar charts.
Measured: Up to 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start13 Mar 2007
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presbyopia CorrectionStudies 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
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIS, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Berry, PhD, Principal investigator, VIS, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702020
- Sponsor's protocol ID
- VIS Opti-K-Presbyopia #002
- Acronym
- VIS Opti-K 002
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIS Opti-K Vision Improvement for Presbyopes
- ClinicalTrials.gov ID
- NCT06702020
- Acronym / sponsor ID
- VIS Opti-K 002 / VIS Opti-K-Presbyopia #002
- Conditions
- Presbyopia Correction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- VIS, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2007 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 22 Nov 2024 (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 VIS Opti-K device and procedure were used to provide vision improvement to patients with presbyopia.
Detailed description
The VIS Opti-K device was used to irradiate the cornea with light that changed corneal shape.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients had documented presbyopia and a need for near vision improvement
Key inclusion criteria (1 listed)
- Female or male Any race 40 years of age or older Presbyopia
Key exclusion criteria (2 listed)
- None
- -
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 distance and near visual acuities
Time frame: Up to 24 months post-treatment
Uncorrected distance and near visual acuities are measured using ETDRS or similar charts.
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 22 Nov 2024.
- VIS, Inc websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Privacy
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Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections With EDOF IOLs
Presbyopia
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.
Michael J Berry, PhD principal investigator
VIS, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia Correction, run by VIS, Inc..
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 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Uncorrected distance and near visual acuities (time frame: Up to 24 months post-treatment). 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 22 Nov 2024.