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.
Cataract, Aphakic Eye, Pseudophakia
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.
Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900
-
NorthEast Eye Research Associates, Woburn, Massachusetts, United States, 01801
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
22 Years to
ALL
Yes
Tomey Corporation,
Ioanis Panagiotopoulos, Dr., PRINCIPAL_INVESTIGATOR, NorthEast Eye Research Associates
2023-10-31