HyperopiaOpti-K PresNCT06597292
The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.
A study testing Vision improvement in people with Hyperopia and Presbyopia, run by VIS, Inc. at 2 sites in 2 countries.
Trial summary
The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperopia, Presbyopia
- What is being tested?
- Vision improvement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Sep 2024to 30 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who meet all of the following criteria are candidates for this study:
- Male or Female
- Any race
- Patient is at least 40 years old.
- Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
- Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.
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- Patient has uncorrected distance visual acuity (UDVA) of 20/100 or better (i.e., LogMAR ≤ 0.70) in both eyes.
- Patient has best corrected distance visual acuity (CDVA) of 20/20 or better (i.e., LogMAR ≤ 0.00) in both eyes.
- Patient has uncorrected near visual acuity (UNVA) between 20/50 (LogMAR 0.40) and better than 20/100 (LogMAR \< 0.70) in eye(s) to be treated.
- Patient has best corrected near visual acuity (CNVA) of at least 20/20 (LogMAR ≤ 0.00) in eye(s) to be treated.
- Patient requires reading adds of +1.0 to +3.0 D in eye(s) to be treated.
- Patient is not a contact lens (CL) wearer.
- Patient has normal corneal topography.
- Patient is willing and able to comply with all examinations.
- Patient must be competent to sign an informed consent form before study entry.
Who cannot join
- Subjects who meet any of the following criteria are to be excluded from this study:
- Corneal disease or corneal disorder in either eye.
- Any active ocular surface disease of any severity.
- Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
- Previous corneal surgery in the eye to be treated.
- Conjunctivochalasis
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- Nystagnus
- Diabetes
- Pregnancy
- Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.
- nclusion Criteria: -
- -
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
VIS, Inc.
Austin, Texas, 78731
Michael Berry, PhD, 831-869-1384, mberry177@gmail.com
Canada1 site
Clarity Eye Institute
Toronto, Ontario, L4K 0J4
Arvind Kattar, 416-278-3202, akattar@clarityeye.ca
:Paul Sanghera, MD
About this study
Official title: Vision Improvement for Patients With Presbyopia
The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).
- Conditions
- Hyperopia, Presbyopia
- Being tested
- Vision improvement
- Keywords
- Vision improvement
- Medical subject headings
- Hyperopia, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision improvementDevice
Vision improvement for patients with refractive disorders (hyperopia and presbyopia)
| Study group | Role | What they receive |
|---|---|---|
| Vision improvement | Experimental | Not described Receives: Device: Vision improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Distance Visual Acuity (UDVA)
Uncorrected distance visual acuity (UDVA) is to be measured and reported using standard ETDRS visual acuity charts. UDVA change from baseline is also to be reported.
Measured: Up to 24 months post-treatment
Uncorrected Near Visual Acuity (UNVA)
Uncorrected near visual acuity (UNVA) is to be measured and reported using standard near visual acuity charts. UNVA change from baseline is also to be reported.
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 posted19 Sep 2024
- Study start16 Sep 2024 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperopiaStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIS, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Berry, PhD, Study director, VIS, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597292
- Sponsor's protocol ID
- VIS Opti-K-Presbyopia #001
- Acronym
- Opti-K Pres
- Status last verified
- Sep 2024
- First submitted
- 30 Aug 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision Improvement for Patients With Presbyopia
- ClinicalTrials.gov ID
- NCT06597292
- Acronym / sponsor ID
- Opti-K Pres / VIS Opti-K-Presbyopia #001
- Conditions
- Hyperopia, Presbyopia
- Keywords
- Vision improvement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- VIS, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Sep 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 Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vision improvement | Experimental | Device: Vision improvement |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or Female
- Any race
- Patient is at least 40 years old.
- Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
- Patient has manifest refraction, spherical equivalent (MRSE) between -0.50 D to 2.50 D, with no more than 1.0 D of refractive cylinder, in eye(s) to be treated.
Key exclusion criteria (12 listed)
- Corneal disease or corneal disorder in either eye.
- Any active ocular surface disease of any severity.
- Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma.
- Previous corneal surgery in the eye to be treated.
- Conjunctivochalasis
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 |
|---|---|---|
| Vision improvementVision improvement for patients with refractive disorders (hyperopia and presbyopia) | Device | Vision improvement |
Primary outcome
Uncorrected Distance Visual Acuity (UDVA)
Time frame: Up to 24 months post-treatment
Uncorrected distance visual acuity (UDVA) is to be measured and reported using standard ETDRS visual acuity charts. UDVA change from baseline is also to be reported.
Uncorrected Near Visual Acuity (UNVA)
Time frame: Up to 24 months post-treatment
Uncorrected near visual acuity (UNVA) is to be measured and reported using standard near visual acuity charts. UNVA change from baseline is also to be reported.
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 25 Sep 2024.
- Individual participant dataSharing planned: No
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School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
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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.
Michael Berry, PhD study director
VIS, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vision improvement in people with Hyperopia and Presbyopia, run by VIS, Inc. at 2 sites in 2 countries.
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 15 inclusion and 12 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: opening soon, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
Contact Michael Berry, PhD (8318691384, mberry177@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Distance Visual Acuity (UDVA) (time frame: Up to 24 months post-treatment). 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 25 Sep 2024.