Subjects Presenting With Normal Eyes
Conditions
Keywords
no known ocular pathology
Brief summary
The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.
Detailed description
Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.
Interventions
DEVICE3D OCT-1 Maestro
OCT Machine used for diagnostic purposes
Sponsors
Topcon Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants must be at least 18 years of age 2. They must be able to complete all testing (all OCT scans) 3. They must volunteer to be in the study and sign the consent form
Exclusion criteria
1. Subject with history of ocular disease or ocular pathology 2. TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off value.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TopQ Cut Off | 1 hour | To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Presenting With Normal Eyes Subjects with no known ocular diseases will be scanned on the Maestro device
3D OCT-1 Maestro: OCT Machine used for diagnostic purposes | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Subjects Presenting With Normal Eyes |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 43.17 years STANDARD_DEVIATION 13.48 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
TopQ Cut Off
To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.
Time frame: 1 hour
Population: use of 12 subjects for 3 different scan patterns
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12x9 Wide Scan | TopQ Cut Off | Standard Deviation Above Threshold | 2.94 microns |
| 12x9 Wide Scan | TopQ Cut Off | Standard Deviation Below Threshold | 17.54 microns |
| 6x6 Macula Scan | TopQ Cut Off | Standard Deviation Above Threshold | 1.5 microns |
| 6x6 Macula Scan | TopQ Cut Off | Standard Deviation Below Threshold | 13.67 microns |
| 6x6 Disc Scan | TopQ Cut Off | Standard Deviation Above Threshold | 2.14 microns |
| 6x6 Disc Scan | TopQ Cut Off | Standard Deviation Below Threshold | 13.67 microns |