Astigmatism, Hyperopia, Myopia, Presbyopia
Conditions
Brief summary
Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.
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
Sponsors
Pete Kollbaum, OD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Questionnaire Response | at Visit 5 (final visit), up to 5 weeks | Patient questions of refraction preference for quickness, efficiency, comfort, and stress |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 58 |
| 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 | 61 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 15 |
Baseline characteristics
| Characteristic | R-Refraction Then S-Refraction | S-Refraction Then R-Refraction | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 49 Participants | 98 Participants |
| Age, Continuous | 41.19 years STANDARD_DEVIATION 17.57 | 38.28 years STANDARD_DEVIATION 18.81 | 39.77 years STANDARD_DEVIATION 18.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 60 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 47 Participants | 95 Participants |
| Region of Enrollment United States | 58 participants | 61 participants | 119 participants |
| Sex: Female, Male Female | 47 Participants | 43 Participants | 90 Participants |
| Sex: Female, Male Male | 11 Participants | 18 Participants | 29 Participants |
| Subject Classification Count : Presbyopes | 31 Participants | 28 Participants | 59 Participants |
| Subject Classification Count : Young Adults | 27 Participants | 33 Participants | 60 Participants |
| Subject Classification: Mean Age Presbyopes | 56.26 years STANDARD_DEVIATION 6.07 | 57.39 years STANDARD_DEVIATION 7.06 | 56.80 years STANDARD_DEVIATION 6.52 |
| Subject Classification: Mean Age Young Adults | 23.89 years STANDARD_DEVIATION 7.27 | 22.06 years STANDARD_DEVIATION 5.52 | 22.88 years STANDARD_DEVIATION 6.38 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 119 |
| other Total, other adverse events | 0 / 119 | 0 / 119 |
| serious Total, serious adverse events | 0 / 119 | 0 / 119 |
Outcome results
Primary
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Quickness | Prefer VR800 | 22 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Quickness | Prefer Standard | 5 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Quickness | No Preference | 15 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Efficiency | Prefer VR800 | 25 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Efficiency | Prefer Standard | 4 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Efficiency | No Preference | 13 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Comfort | Prefer VR800 | 26 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Comfort | Prefer Standard | 5 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Comfort | No Preference | 11 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Stress | Prefer VR800 | 16 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Stress | Prefer Standard | 7 Participants |
| R-Refraction Then S-Refraction | Subjective Questionnaire Response | Stress | No Preference | 19 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Stress | Prefer Standard | 10 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Quickness | Prefer VR800 | 32 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Comfort | Prefer VR800 | 21 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Quickness | Prefer Standard | 3 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Stress | Prefer VR800 | 19 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Quickness | No Preference | 11 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Comfort | Prefer Standard | 6 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Efficiency | Prefer VR800 | 26 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Stress | No Preference | 17 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Efficiency | Prefer Standard | 4 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Comfort | No Preference | 19 Participants |
| S-Refraction Then R-Refraction | Subjective Questionnaire Response | Efficiency | No Preference | 16 Participants |
Comparison: Added the number of participants from each study arm who preferred each refraction type and then converted it to the proportions