An observational study in Subjects Presenting With Normal Eyes, sponsored by Topcon Medical Systems, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-29.
Sponsored by Topcon Medical Systems, Inc. (part of Topcon Corporation) · Observational
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The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.
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.
Topcon Medical Systems, Inc. is the lead sponsor of 26 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with no known eye disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Subjects with no known ocular diseases will be scanned on the Maestro device
Device: 3D OCT-1 Maestro
OCT Machine used for diagnostic purposes
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
| Milestone | Subjects Presenting With Normal Eyes |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| microns | 12x9 Wide Scan | 6x6 Macula Scan | 6x6 Disc Scan |
|---|---|---|---|
| Standard Deviation Above Threshold | 2.94 | 1.5 | 2.14 |
| Standard Deviation Below Threshold | 17.54 | 13.67 | 13.67 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Presenting With Normal Eyes | — | 0/12 (0%) | 0/12 (0%) |
Normal healthy eyes without any known eye conditions
| Age, Categorical(Participants) | Subjects Presenting With Normal Eyes |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 1 |
| Age, Continuous(years) | Subjects Presenting With Normal Eyes |
|---|---|
| Mean | 43.17 ± 13.48 |
| Sex: Female, Male(Participants) | Subjects Presenting With Normal Eyes |
|---|---|
| Female | 7 |
| Male | 5 |
| Region of Enrollment(participants) | Subjects Presenting With Normal Eyes |
|---|---|
| United States | 12 |
The record gives a start of May 2015, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2017, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Topcon Medical Systems, Inc. →