Trial Outcomes & Findings for Clinical Investigation of the Vision-R800 Device. (NCT NCT04208750)
NCT ID: NCT04208750
Last Updated: 2022-03-14
Results Overview
Patient questions of refraction preference for quickness, efficiency, comfort, and stress
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
119 participants
Primary outcome timeframe
at Visit 5 (final visit), up to 5 weeks
Results posted on
2022-03-14
Participant Flow
Participant milestones
| Measure |
R-Refraction Then S-Refraction
Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
|
S-Refraction Then R-Refraction
Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
61
|
|
Overall Study
Visit 2
|
58
|
61
|
|
Overall Study
Visit 3
|
58
|
53
|
|
Overall Study
Visit 4
|
43
|
47
|
|
Overall Study
COMPLETED
|
42
|
46
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
Reasons for withdrawal
| Measure |
R-Refraction Then S-Refraction
Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
|
S-Refraction Then R-Refraction
Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
15
|
Baseline Characteristics
Sub-populations of participants were assessed for this baseline measure (young adults and presbyopes).
Baseline characteristics by cohort
| Measure |
R-Refraction Then S-Refraction
n=58 Participants
Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
|
S-Refraction Then R-Refraction
n=61 Participants
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
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=58 Participants
|
8 Participants
n=61 Participants
|
15 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=58 Participants
|
2 Participants
n=61 Participants
|
3 Participants
n=119 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=58 Participants
|
47 Participants
n=61 Participants
|
95 Participants
n=119 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=58 Participants
|
4 Participants
n=61 Participants
|
6 Participants
n=119 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=119 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=58 Participants
|
61 participants
n=61 Participants
|
119 participants
n=119 Participants
|
|
Subject Classification
Count : Young Adults
|
27 Participants
n=58 Participants
|
33 Participants
n=61 Participants
|
60 Participants
n=119 Participants
|
|
Subject Classification
Count : Presbyopes
|
31 Participants
n=58 Participants
|
28 Participants
n=61 Participants
|
59 Participants
n=119 Participants
|
|
Subject Classification: Mean Age
Young Adults
|
23.89 years
STANDARD_DEVIATION 7.27 • n=27 Participants • Sub-populations of participants were assessed for this baseline measure (young adults and presbyopes).
|
22.06 years
STANDARD_DEVIATION 5.52 • n=33 Participants • Sub-populations of participants were assessed for this baseline measure (young adults and presbyopes).
|
22.88 years
STANDARD_DEVIATION 6.38 • n=60 Participants • Sub-populations of participants were assessed for this baseline measure (young adults and presbyopes).
|
|
Subject Classification: Mean Age
Presbyopes
|
56.26 years
STANDARD_DEVIATION 6.07 • n=31 Participants • Sub-populations of participants were assessed for this baseline measure (young adults and presbyopes).
|
57.39 years
STANDARD_DEVIATION 7.06 • n=28 Participants • Sub-populations of participants were assessed for this baseline measure (young adults and presbyopes).
|
56.80 years
STANDARD_DEVIATION 6.52 • n=59 Participants • Sub-populations of participants were assessed for this baseline measure (young adults and presbyopes).
|
|
Age, Categorical
<=18 years
|
6 Participants
n=58 Participants
|
8 Participants
n=61 Participants
|
14 Participants
n=119 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=58 Participants
|
49 Participants
n=61 Participants
|
98 Participants
n=119 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=58 Participants
|
4 Participants
n=61 Participants
|
7 Participants
n=119 Participants
|
|
Age, Continuous
|
41.19 years
STANDARD_DEVIATION 17.57 • n=58 Participants
|
38.28 years
STANDARD_DEVIATION 18.81 • n=61 Participants
|
39.77 years
STANDARD_DEVIATION 18.14 • n=119 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=58 Participants
|
43 Participants
n=61 Participants
|
90 Participants
n=119 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=58 Participants
|
18 Participants
n=61 Participants
|
29 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=58 Participants
|
1 Participants
n=61 Participants
|
6 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=58 Participants
|
60 Participants
n=61 Participants
|
112 Participants
n=119 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=58 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=119 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=119 Participants
|
PRIMARY outcome
Timeframe: at Visit 5 (final visit), up to 5 weeksPatient questions of refraction preference for quickness, efficiency, comfort, and stress
Outcome measures
| Measure |
R-Refraction Then S-Refraction
n=42 Participants
Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
|
S-Refraction Then R-Refraction
n=46 Participants
Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses
Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses
|
|---|---|---|
|
Subjective Questionnaire Response
Quickness · Prefer VR800
|
22 Participants
|
32 Participants
|
|
Subjective Questionnaire Response
Quickness · Prefer Standard
|
5 Participants
|
3 Participants
|
|
Subjective Questionnaire Response
Quickness · No Preference
|
15 Participants
|
11 Participants
|
|
Subjective Questionnaire Response
Efficiency · Prefer VR800
|
25 Participants
|
26 Participants
|
|
Subjective Questionnaire Response
Efficiency · Prefer Standard
|
4 Participants
|
4 Participants
|
|
Subjective Questionnaire Response
Efficiency · No Preference
|
13 Participants
|
16 Participants
|
|
Subjective Questionnaire Response
Comfort · Prefer VR800
|
26 Participants
|
21 Participants
|
|
Subjective Questionnaire Response
Comfort · Prefer Standard
|
5 Participants
|
6 Participants
|
|
Subjective Questionnaire Response
Comfort · No Preference
|
11 Participants
|
19 Participants
|
|
Subjective Questionnaire Response
Stress · Prefer VR800
|
16 Participants
|
19 Participants
|
|
Subjective Questionnaire Response
Stress · Prefer Standard
|
7 Participants
|
10 Participants
|
|
Subjective Questionnaire Response
Stress · No Preference
|
19 Participants
|
17 Participants
|
Adverse Events
R-Refraction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
S-Refraction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place