Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-Refraction | Experimental |
| |
| S-Refraction | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vision R-800 Phoropter | Device | Refraction utilizing the Vision R-800 Phoropter with resulting glasses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Questionnaire Response | Patient questions of refraction preference for quickness, efficiency, comfort, and stress | at Visit 5 (final visit), up to 5 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Clinical Optics Research Lab | Bloomington | Indiana | 47405 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | S-Refraction Then R-Refraction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Questionnaire Response | Patient questions of refraction preference for quickness, efficiency, comfort, and stress | Posted | Count of Participants | Participants | at Visit 5 (final visit), up to 5 weeks |
|
5 weeks for each participant
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R-Refraction | Vision R-800 Phoropter: Refraction utilizing the Vision R-800 Phoropter with resulting glasses |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dawn Meyer | Indiana University | 812-855-0559 | meyerd@indiana.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2019 | Jan 5, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2020 | Jan 5, 2022 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Phoropter | Device | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Subject Classification | young adult = someone without presbyopia, does not require a near addition presbyope = someone with presbyopia, requires a near addition | Count of Participants | Participants |
|
| Subject Classification: Mean Age | young adult = someone without presbyopia, does not require a near addition presbyope = someone with presbyopia, requires a near addition | Sub-populations of participants were assessed for this baseline measure (young adults and presbyopes). | Mean | Standard Deviation | years |
|
|
|
|
| 0 |
| 119 |
| 0 |
| 119 |
| 0 |
| 119 |
| EG001 | S-Refraction | Standard Phoropter: Refraction utilizing the standard phoropter with resulting glasses | 0 | 119 | 0 | 119 | 0 | 119 |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No Preference |
|
| No Preference |
|
| No Preference |
|