MyopiaPhase 4NCT04208750

Clinical Investigation of the Vision-R800 Device.

A Phase 4 study testing Vision R-800 Phoropter and Standard Phoropter in people with Myopia and Hyperopia, run by Pete Kollbaum, OD, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Myopia, Hyperopia, Astigmatism
What is being tested?: Vision R-800 Phoropter and Standard Phoropter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteUnited States
Study dates: 18 Nov 2019to 1 Feb 2021
Phase: Phase 4
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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

current adaptated progressive addition lens wearer, if bifocal lens required
wearable pair of glasses < 2 years old
wear glasses at least 6 hours per day

Who cannot join

Eye Disease with an impact on visual acuity or binocular vision abnormalities (by self-report)
Formal training in optometry, vision science or in the eyecare field

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Clinical Optics Research Lab
Bloomington, Indiana, 47405

Other trials in United States

About this study

Official title: Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2

Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.

Conditions: Myopia, Hyperopia, Astigmatism, Presbyopia
Being tested: Vision R-800 Phoropter, Standard Phoropter
Medical subject headings: Myopia, Hyperopia, Astigmatism, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vision R-800 PhoropterDevice
Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Standard PhoropterDevice
Refraction utilizing the standard phoropter with resulting glasses

Study groups in NCT04208750
Study group	Role	What they receive
R-Refraction	Experimental	Not described Receives: Device: Vision R-800 Phoropter; Device: Standard Phoropter
S-Refraction	Active comparator	Not described Receives: Device: Vision R-800 Phoropter; Device: Standard Phoropter

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective Questionnaire Response
Patient questions of refraction preference for quickness, efficiency, comfort, and stress
Measured: at Visit 5 (final visit), up to 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 20191 Feb 2021

First posted23 Dec 2019
Study start18 Nov 2019
Primary completion1 Feb 2021
Study completion1 Feb 2021

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.
Other trials for MyopiaStudies 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 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04208750
Sponsor's protocol ID: Kollbaum003
Status last verified: Feb 2022
First submitted: 14 Nov 2019
Last updated: 14 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2
ClinicalTrials.gov ID: NCT04208750
Acronym / sponsor ID: Kollbaum003
Conditions: Myopia, Hyperopia, Astigmatism, Presbyopia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Pete Kollbaum, OD, PhDUniversity, hospital or other
Study start: 18 Nov 2019 (actual)
Primary completion: 1 Feb 2021 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 23 Dec 2019 (actual)
Results: Posted 14 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
R-Refraction	Experimental	Device: Vision R-800 Phoropter, Device: Standard Phoropter
S-Refraction	Active comparator	Device: Vision R-800 Phoropter, Device: Standard Phoropter

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

current adaptated progressive addition lens wearer, if bifocal lens required
wearable pair of glasses < 2 years old
wear glasses at least 6 hours per day

Key exclusion criteria (2 listed)

Eye Disease with an impact on visual acuity or binocular vision abnormalities (by self-report)
Formal training in optometry, vision science or in the eyecare field

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 R-800 PhoropterRefraction utilizing the Vision R-800 Phoropter with resulting glasses	Device	R-Refraction, S-Refraction
Standard PhoropterRefraction utilizing the standard phoropter with resulting glasses	Device	R-Refraction, S-Refraction

Primary outcome

Subjective Questionnaire Response
Time frame: at Visit 5 (final visit), up to 5 weeks
Patient questions of refraction preference for quickness, efficiency, comfort, and stress

Results and safety

Results posted to the registry on 14 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
R-Refraction Then S-Refraction	58	42
S-Refraction Then R-Refraction	61	46

Primary outcome: Subjective Questionnaire Response

Time frame: at Visit 5 (final visit), up to 5 weeks. Count of participants. Unit: Participants

Measure	R-Refraction Then S-Refraction n = 42	S-Refraction Then R-Refraction n = 46
Quickness: Prefer VR800	22	32
Quickness: Prefer Standard	5	3
Quickness: No Preference	15	11
Efficiency: Prefer VR800	25	26
Efficiency: Prefer Standard	4	4
Efficiency: No Preference	13	16
Comfort: Prefer VR800	26	21
Comfort: Prefer Standard	5	6

Adverse events

Time frame: 5 weeks for each participant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R-Refraction	0 of 119 (0%)	0 of 119 (0%)	0 of 119
S-Refraction	0 of 119 (0%)	0 of 119 (0%)	0 of 119

Limitations and caveats (from the sponsor): Due to the COVID-19 pandemic this study was interrupted. Therefore, obtaining complete in-office data for some subjects was not possible. However, for all subjects possible at-home data was still obtained, as well as any in-office data that could be obtained remotely. Under allowed protocol deviation, some data was also collected in July following re-opening of the lab. We did rule out an effect of in-office as compared to remote data due to the COVID-19 pandemic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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?

A Phase 4 study testing Vision R-800 Phoropter and Standard Phoropter in people with Myopia and Hyperopia, run by Pete Kollbaum, OD, PhD 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 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 14 Mar 2022. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2022). 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?

Subjective Questionnaire Response (time frame: at Visit 5 (final visit), up to 5 weeks). 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 NCT04208750.

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 14 Mar 2022.