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This is a prospective comparative study that will be conducted at one clinical site in the United States, in which subjects who sign an informed consent form and fulfil all inclusion and exclusion criteria, will have OCT scans obtained using the test and the predicate devices.
There will be two main types of analyses performed as part of this study, including 1) a precision analysis, and 2) an agreement analysis.
The precision analyses will be conducted utilizing all complete complements of acceptable scans from the test devices and predicate device for each of the 3 configurations. A complete complement of acceptable scans can be defined as subjects having 3 acceptable replicate scans on each of the 3 devices, at each of the 3 configurations. This is also synonymous with 3 scans for each of the 3 configurations on all 3 devices. If subjects have more than 3 acceptable scans per configuration on a device, only the first 3 will be considered for analyses.
The agreement analysis will be conducted utilizing the first set of acceptable scans from each instrument for all overlapping measurement types (for all measurement types two or more of the devices have in common) related to performance endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal |
| ||
| Cataract |
| ||
| Special eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical measurement | Device | Optical measurements by optical biometers and an OCT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between the test devices and predicate device | Agreement between each of the test devices and the predicate device will be evaluated by the mean difference and SD, the 95% limits of agreement (LOA), the Bland-Altman plots, and Deming regression for each subject population. | Through study completion, approximately 4 months |
| Precision of the test devices | A crossed two-way random-effects analysis of variance (ANOVA) model will be used to estimate the repeatability and reproducibility limits of each scan parameter by subject population and study device (test and predicate device). This ANOVA model will include the configuration, subject, and interaction between configuration and subject as the factors. Repeatability and reproducibility standard deviations, as well as the corresponding coefficient of variations (CVs), will be calculated using this ANOVA model. | Through study completion, approximately 4 months |
| Safety of the test devices | Adverse events reported will be listed by subject. | Through study completion, approximately 4 months |
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Inclusion Criteria - Normal Cohort:
Inclusion Criteria - Cataract Cohort:
Inclusion Criteria - Special Eyes Cohort (eyes without a natural lens or eyes containing artificial materials):
Exclusion Criteria - Normal Cohort:
Exclusion Criteria - Cataract Cohort:
Exclusion Criteria - Special Eyes Cohort (eyes without a natural lens or eyes containing artificial materials):
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Normal subjects (22 years of age or older) Cataract subjects (22 years of age or older), Special eyes subjects (22 years of age or older)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deep Soni | Contact | 857-250-9178 | deep@neeraeye.com |
| Name | Affiliation | Role |
|---|---|---|
| Ioanis Panagiotopoulos, Dr. | NorthEast Eye Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthEast Eye Research Associates | Recruiting | Woburn | Massachusetts | 01801 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001035 | Aphakia |
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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