CompletedNCT04208750Updated Mar 14, 2022Results posted

Clinical Investigation of the Vision-R800 Device.

A Phase 4 interventional study of Vision R-800 Phoropter and Standard Phoropter in Myopia, Hyperopia and Astigmatism, sponsored by Pete Kollbaum, OD, PhD. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-14.

Sponsored by Pete Kollbaum, OD, PhD · Phase 4, Interventional, and Diagnostic

Phase: Phase 4
Study type: Interventional
Enrollment: 119
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

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

Conditions studied

Myopia
Hyperopia
Astigmatism
Presbyopia

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In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's enrollment of 119 is above the median of 78 across 923 interventional studies indexed under Myopia.

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Lead sponsor

Pete Kollbaum, OD, PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 4
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 119 participants (actual)

Study arms

Experimental
R-Refraction
Device: Vision R-800 Phoropter · Device: Standard Phoropter
Active comparator
S-Refraction
Device: Vision R-800 Phoropter · Device: Standard Phoropter

Interventions

DeviceVision R-800 Phoropter
Refraction utilizing the Vision R-800 Phoropter with resulting glasses
DeviceStandard Phoropter
Refraction utilizing the standard phoropter with resulting glasses

What researchers measure

Primary outcomes

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

Results

Posted Mar 14, 2022

Limitations and caveats

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.

Participant flow

Participant flow — Overall Study
Milestone	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction
Started	58	61
Visit 2	58	61
Visit 3	58	53
Visit 4	43	47
Completed	42	46
Not completed	16	15
Withdrew: Lost to follow-up	16	15

Outcome measures

PrimarySubjective Questionnaire Response

Patient questions of refraction preference for quickness, efficiency, comfort, and stress

Time frame:: at Visit 5 (final visit), up to 5 weeks
Reported as:: Count of participants · Participants

Subjective Questionnaire Response
Participants	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction
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
Comfort — No Preference	11	19
Stress — Prefer VR800	16	19
Stress — Prefer Standard	7	10
Stress — No Preference	19	17

Statistical analysis

R-Refraction Then S-Refraction vs S-Refraction Then R-Refraction ·

Adverse events

Collected over 5 weeks for each participant. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
R-Refraction	0/119 (0%)	0/119 (0%)	0/119 (0%)
S-Refraction	0/119 (0%)	0/119 (0%)	0/119 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction	Total
<=18 years	6	8	14
Between 18 and 65 years	49	49	98
>=65 years	3	4	7

Age, Continuous
Age, Continuous(years)	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction	Total
Mean	41.19 ± 17.57	38.28 ± 18.81	39.77 ± 18.14

Sex: Female, Male
Sex: Female, Male(Participants)	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction	Total
Female	47	43	90
Male	11	18	29

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction	Total
Hispanic or Latino	5	1	6
Not Hispanic or Latino	52	60	112
Unknown or Not Reported	1	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction	Total
American Indian or Alaska Native	0	0	0
Asian	7	8	15
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	2	3
White	48	47	95
More than one race	2	4	6
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction	Total
United States	58	61	119

Subject Classification
Subject Classification(Participants)	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction	Total
Count : Young Adults	27	33	60
Count : Presbyopes	31	28	59

Subject Classification: Mean Age
Subject Classification: Mean Age(years)	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction	Total
Young Adults	23.89 ± 7.27	22.06 ± 5.52	22.88 ± 6.38
Presbyopes	56.26 ± 6.07	57.39 ± 7.06	56.80 ± 6.52

Study locations

1 site

Indiana University Clinical Optics Research Lab
Bloomington, Indiana 47405, United States

References and documents

Study documents

Study protocol ↗ · Aug 5, 2019
Statistical analysis plan ↗ · Feb 3, 2020

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2019 to primary completion in Feb 2021, 14 months.

Results were first posted in Mar 2022, 1 year 1 month after primary completion.

Of 18 phase 4 interventional studies under Myopia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 29. This study's 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 14, 2019
First posted: Dec 23, 2019
StartActual: Nov 18, 2019
Primary completionActual: Feb 1, 2021
CompletionActual: Feb 1, 2021
Results first posted: Mar 14, 2022
Last update: Mar 14, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04208750
Lead sponsor: Pete Kollbaum, OD, PhD
Responsible party: Pete Kollbaum, OD, PhD (Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research, Indiana University) — Sponsor-investigator
First posted: Dec 23, 2019
Start date: Nov 18, 2019
Primary completion: Feb 1, 2021
Completion: Feb 1, 2021
Results posted: Mar 14, 2022
Last update: Mar 14, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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