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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Normal Eyes | The eye will be imaged up to seven times with the biometer to achieve three acceptable scans |
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| Group 2 - Eyes with cataracts | The eye will be imaged up to seven times with the biometer to achieve three acceptable scans |
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| Group 3 - Eyes with significant refractive errors | The eye will be imaged up to seven times with the biometer to achieve three acceptable scans |
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| Group 4 - Eyes with abnormal corneal topography | The eye will be imaged up to seven times with the biometer to achieve three acceptable scans |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Biometer | Device | Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Central corneal thickness (CCT) | 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. | Day 1 |
| Lens thickness (LT) | 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. | Day 1 |
| Anterior chamber depth (regression) (ACD-R) | 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. | Day 1 |
| Axial length (regression) (AL-R) | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Depth Sum of Segments (ACD-SoS) | 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Cohorts will be selected from approximately one investigative site located in the United States.
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| Name | Affiliation | Role |
|---|---|---|
| Arnold Ouyang, PhD | Cylite Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthEast Eye Research Associates LLC | Woburn | Massachusetts | 01801 | United States |
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| IOLMaster 700 Biometer | Device | Commercially available non-contact instrument used to capture optical biometry measurements |
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| Axial Length Sum of Segments (AL-SoS) | 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. | Day 1 |