Clinical Investigation of the Vision-R800 Device.

• Sponsor: Pete Kollbaum, OD, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT04208750
• Collaborator: (none)
• Enrollment: 119
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia; Astigmatism; Presbyopia	Device: Vision R-800 Phoropter; Device: Standard Phoropter	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2
• Actual Study Start Date: Nov 18, 2019
• Actual Primary Completion Date: Feb 1, 2021
• Actual Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: R-Refraction	Device: Vision R-800 Phoropter; Refraction utilizing the Vision R-800 Phoropter with resulting glasses; Device: Standard Phoropter; Refraction utilizing the standard phoropter with resulting glasses
Active Comparator: S-Refraction	Device: Vision R-800 Phoropter; Refraction utilizing the Vision R-800 Phoropter with resulting glasses; Device: Standard Phoropter; Refraction utilizing the standard phoropter with resulting glasses

Outcome Measures

Primary Outcome Measures

1. Subjective Questionnaire Response [at Visit 5 (final visit), up to 5 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Clinical Optics Research Lab	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Pete Kollbaum, OD, PhD

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 5, 2019
• Statistical Analysis Plan - Feb 3, 2020

More Information

Publications

None provided.

• Responsible Party: Pete Kollbaum, OD, PhD, Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research, Indiana University
• ClinicalTrials.gov Identifier: NCT04208750
• Other Study ID Numbers: Kollbaum003
• First Posted: Dec 23, 2019
• Last Update Posted: Mar 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Astigmatism; Presbyopia; Hyperopia

Study Results

Participant Flow

Arm/Group Title	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction
Arm/Group Description	Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses	Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
Period Title: Overall Study
STARTED	58	61
Visit 2	58	61
Visit 3	58	53
Visit 4	43	47
COMPLETED	42	46
NOT COMPLETED	16	15

Baseline Characteristics

Arm/Group Title	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction	Total
Arm/Group Description	Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses	Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses	Total of all reporting groups
Overall Participants	58	61	119
Age (Count of Participants)
<=18 years	6 10.3%	8 13.1%	14 11.8%
Between 18 and 65 years	49 84.5%	49 80.3%	98 82.4%
>=65 years	3 5.2%	4 6.6%	7 5.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.19 (17.57)	38.28 (18.81)	39.77 (18.14)
Sex: Female, Male (Count of Participants)
Female	47 81%	43 70.5%	90 75.6%
Male	11 19%	18 29.5%	29 24.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 8.6%	1 1.6%	6 5%
Not Hispanic or Latino	52 89.7%	60 98.4%	112 94.1%
Unknown or Not Reported	1 1.7%	0 0%	1 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	7 12.1%	8 13.1%	15 12.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 1.7%	2 3.3%	3 2.5%
White	48 82.8%	47 77%	95 79.8%
More than one race	2 3.4%	4 6.6%	6 5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	58 100%	61 100%	119 100%
Subject Classification (Count of Participants)
Count : Young Adults	27 46.6%	33 54.1%	60 50.4%
Count : Presbyopes	31 53.4%	28 45.9%	59 49.6%
Subject Classification: Mean Age (years) [Mean (Standard Deviation) ]
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)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-Refraction Then S-Refraction	S-Refraction Then R-Refraction
Arm/Group Description	Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses	Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
Measure Participants	42	46
Prefer VR800	22 37.9%	32 52.5%
Prefer Standard	5 8.6%	3 4.9%
No Preference	15 25.9%	11 18%
Prefer VR800	25 43.1%	26 42.6%
Prefer Standard	4 6.9%	4 6.6%
No Preference	13 22.4%	16 26.2%
Prefer VR800	26 44.8%	21 34.4%
Prefer Standard	5 8.6%	6 9.8%
No Preference	11 19%	19 31.1%
Prefer VR800	16 27.6%	19 31.1%
Prefer Standard	7 12.1%	10 16.4%
No Preference	19 32.8%	17 27.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	R-Refraction Then S-Refraction, S-Refraction Then R-Refraction
	Comments	Added the number of participants from each study arm who preferred each refraction type and then converted it to the proportions
	Type of Statistical Test	Other
	Comments	Difference between independent proportions
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		For each outcome, we compared the proportion of participants from both study arms who preferred the VR800 refraction to the proportion of participants who preferred the Standard refraction using a 2-sample test for equality of proportions.

Adverse Events

Time Frame	5 weeks for each participant
Arm/Group Title	R-Refraction		S-Refraction
Arm/Group Description	Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses		Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
All Cause Mortality
	R-Refraction		S-Refraction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		0/119 (0%)
Serious Adverse Events
	R-Refraction		S-Refraction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		0/119 (0%)
Other (Not Including Serious) Adverse Events
	R-Refraction		S-Refraction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		0/119 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.