PresbyopiaNCT05495971
Extended Depth of Focus Contact Lenses for Presbyopia
A study testing NaturalVue Multifocal in people with Presbyopia, run by Visioneering Technologies, Inc at 1 site in United States.
Trial summary
VTI has an FDA cleared soft contact lens product. Its optical design creates an enhanced depth of focus (EDOF), which provides clear distance, intermediate, and near vision. This study is to quantify the enhanced depth of focus and visual impact. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- NaturalVue Multifocal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 12 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Suitable and able to wear contact lenses
- Normal best corrected vision (20/25 or better)
- Need reading add +2.00 or stronger
Who cannot join
- Pre-existing ocular condition that would contraindicating lens wear
Trial locations and contacts
1 site in 1 country.
About this study
VTI has an FDA cleared soft contact lens product. Its optical design creates an enhanced depth of focus (EDOF), which provides clear distance, intermediate, and near vision. This study is to quantify the enhanced depth of focus and visual impact.
Read the detailed description
This study will develop defocus curves for Baseline best corrected spectacle refraction and then for the EDOF lens used in this study. A comparison of thge depth of focus for each condition will be made.
- Conditions
- Presbyopia
- Being tested
- NaturalVue Multifocal
- Keywords
- soft contact lens
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaturalVue MultifocalDevice
EDOF
| Study group | Role | What they receive |
|---|---|---|
| Presbyopia | Experimental | Subject's baseline vision will be compared with vision wearing treatment product Receives: Device: NaturalVue Multifocal |
What is being measured
The primary outcome is the main question the study is designed to answer.
LogMAR Visual Acuity
High contrast/high illumination distant (6M) logMAR vision
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start6 Sep 2022
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Subjects will serve as their own control using objective baseline data.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visioneering Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas P. Benoit, OD, Study director, Visioneering Technologies, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495971
- Sponsor's protocol ID
- VTI-2206
- Status last verified
- Dec 2024
- First submitted
- 8 Aug 2022
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tuan KA, Benoit DP, O'Connor B. Evaluation of the Functional Visual Range of a Catenary Curve-Based, Extended Depth-of-Focus Contact Lens for Presbyopia. Clin Ophthalmol. 2024 Jul 19;18:2113-2123. doi: 10.2147/OPTH.S468699. eCollection 2024.
PubMed 39055378
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Depth of Focus Contact Lenses for Presbyopia
- ClinicalTrials.gov ID
- NCT05495971
- Acronym / sponsor ID
- VTI-2206
- Conditions
- Presbyopia
- Keywords
- soft contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Visioneering Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VTI has an FDA cleared soft contact lens product. Its optical design creates an enhanced depth of focus (EDOF), which provides clear distance, intermediate, and near vision. This study is to quantify the enhanced depth of focus and visual impact.
Detailed description
This study will develop defocus curves for Baseline best corrected spectacle refraction and then for the EDOF lens used in this study. A comparison of thge depth of focus for each condition will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will serve as their own control using objective baseline data.
| Arm | Type | Receives |
|---|---|---|
| Presbyopia | Experimental | Device: NaturalVue MultifocalSubject's baseline vision will be compared with vision wearing treatment product |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Suitable and able to wear contact lenses
- Normal best corrected vision (20/25 or better)
- Need reading add +2.00 or stronger
Key exclusion criteria (1 listed)
- Pre-existing ocular condition that would contraindicating lens wear
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 |
|---|---|---|
| NaturalVue MultifocalEDOF | Device | Presbyopia |
Primary outcome
LogMAR Visual Acuity
Time frame: 4 hours
High contrast/high illumination distant (6M) logMAR vision
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39055378Tuan KA, Benoit DP, O'Connor B. Evaluation of the Functional Visual Range of a Catenary Curve-Based, Extended Depth-of-Focus Contact Lens for Presbyopia. Clin Ophthalmol. 2024 Jul 19;18:2113-2123. doi: 10.2147/OPTH.S468699. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Douglas P. Benoit, OD study director
Visioneering Technologies, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaturalVue Multifocal in people with Presbyopia, run by Visioneering Technologies, Inc at 1 site in United States.
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 1 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 16 Dec 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
LogMAR Visual Acuity (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495971, which also lists 1 linked publication.
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 16 Dec 2024.