Abnormal Eyes, Normal Eyes
Conditions
Keywords
Biometric measurements
Brief summary
The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of the biometric measurements will be evaluated.
Detailed description
This is intended to be a 1-visit study approximately 3 hours in length with planned duration of exposure of up to 20 minutes per device (investigational biometer and IOLMaster 700). Four cohorts will be enrolled. One eye per subject will be assessed.
Interventions
DEVICEInvestigational Biometer
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters
DEVICEIOLMaster 700 Biometer
Commercially available non-contact instrument used to capture optical biometry measurements
Sponsors
Cylite Pty Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to understand and sign an Institution Review Board approved Informed Consent form. * Willing and able to attend all scheduled study visits as required by the protocol. * Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.
Exclusion criteria
* Unable to fixate, for example, due to nystagmus or other eye movement abnormality. * Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study. * Active ocular infection or inflammation. * Rigid or contact lens wear during the previous two weeks prior to Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central corneal thickness (CCT) | Day 1 | Central corneal thickness will be measured in microns. This outcome measure will be analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods. |
| Lens thickness (LT) | Day 1 | Lens thickness will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods. |
| Anterior chamber depth (regression) (ACD-R) | Day 1 | Anterior chamber depth (the physical length from the anterior cornea to the anterior lens) will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods. |
| Axial length (regression) (AL-R) | Day 1 | Axial length (the distance between the back and front of the eye) will be measured in millimeters and analyzed using Bland-Altman Limits of Agreement, repeatability, reproducibility, and percent coefficient of variation (repeatability and reproducibility) methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Depth Sum of Segments (ACD-SoS) | Day 1 | ACD-SoS is calculated by calculating the individual corneal thickness and aqueous depth segments, applying the known refractive indices for each segment, and summing the resultant measurement of each segment. ACD-SoS will be measured in microns and analyzed using Bland-Altman Limits of Agreement, repeatability, and reproducibility methods. |
| Axial Length Sum of Segments (AL-SoS) | Day 1 | AL-SoS is calculated by calculating the individual corneal thickness, aqueous depth, lens thickness and vitreous length segments, applying the known refractive indices for each segment, and summing the resultant measurement of each segment. AL-SoS will be measured in millimeters and analyzed using using Bland-Altman Limits of Agreement, repeatability, and reproducibility methods. |
Countries
United States
Outcome results
None listed