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This is a non-interventional prospective, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the Orbscan II compared to the IOL Master 700 (Zeiss), IOL Master 500 (Zeiss), Atlas 9000 (Zeiss), Lenstar 900 (Haag-Streit), Argos (Alcon), iTrace (Tracey), Pentacam (Oculus), and manual calipers.
This is a non-interventional prospective, single center, bilateral, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the Orbscan II compared to the IOL Master 700 (Zeiss), IOL Master 500 (Zeiss), Atlas 9000 (Zeiss), Lenstar 900 (Haag-Streit), Argos (Alcon), iTrace (Tracey), Pentacam (Oculus), and manual calipers. Additional biometric devices or external photography may be included as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myopic -1.00D | Myopic patients with a diopter of at least -1.00 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orbscan II | Diagnostic Test | Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Correlation of White-to-white Measurements Between Biometric Devices. | The determination of the degree of correlation of white-to-white measurements between various biometric devices and the Orbscan II. | Day of visit |
| The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. | The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices and the Orbscan II. | Day of visit |
| The Correlation of Corneal Thickness Measurements Between Biometric Devices. | The determination of the degree of correlation of corneal thickness measurements between various biometric devices and the Orbscan II. | Day of visit |
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Inclusion Criteria:
Exclusion Criteria:
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Myopic patients with a spherical equivalent of at least -1.00D with healthy eyes and no prior eye surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Morgan Micheletti, MD | Berkeley Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berkeley Eye Center | Houston | Texas | 77027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Myopic -1.00D | Myopic patients with a diopter of at least -1.00 Orbscan II: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. IOL Master 700: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. IOL Master 500: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Atlas 9000: Diagnostic assessment to measure white-to-white. Lenstar 900: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Pentacam: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. iTrace: Diagnostic assessment to measure white-to-white and corneal thickness. Argos: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Manual caliper measurement: Manual diagnostic assessment to measure white-to-white. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Myopic -1.00D | Myopic patients with a diopter of at least -1.00. All patients will receive scans with each device. Orbscan II: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. IOL Master 700: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. IOL Master 500: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Atlas 9000: Diagnostic assessment to measure white-to-white. Lenstar 900: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Pentacam: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. iTrace: Diagnostic assessment to measure white-to-white and corneal thickness. Argos: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Manual caliper measurement: Manual diagnostic assessment to measure white-to-white. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Correlation of White-to-white Measurements Between Biometric Devices. | The determination of the degree of correlation of white-to-white measurements between various biometric devices and the Orbscan II. | Posted | Number | 95% Confidence Interval | Pearson correlation r | Day of visit | eyes | eyes |
|
Day of visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Argos | Argos biometer | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tetiana Huff | Berkeley Eye Center | 713-620-7640 | tetiana.huff@berkeleyeye.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2023 | May 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| IOL Master 700 | Diagnostic Test | Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. |
|
| IOL Master 500 | Diagnostic Test | Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. |
|
| Atlas 9000 | Diagnostic Test | Diagnostic assessment to measure white-to-white. |
|
| Lenstar 900 | Diagnostic Test | Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. |
|
| Pentacam | Diagnostic Test | Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. |
|
| iTrace | Diagnostic Test | Diagnostic assessment to measure white-to-white and corneal thickness. |
|
| Argos | Diagnostic Test | Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. |
|
| Manual caliper measurement | Diagnostic Test | Manual diagnostic assessment to measure white-to-white. |
|
| eyes |
|
| Participants |
| Participants |
|
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| Sex/Gender, Customized | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| OG003 | IOLMaster 500 | IOLMaster 500 biometer |
| OG004 | IOLMaster 700 | IOLMaster 700 biometer |
| OG005 | iTrace | iTrace device |
| OG006 | Lenstar LS900 | Lenstar LS900 biometer |
| OG007 | Pentacam AXL Wave | Pentacam AXL Wave device |
| OG008 | Pentacam HR | Pentacam HR device |
|
|
| Primary | The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. | The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices and the Orbscan II. | Posted | Number | 95% Confidence Interval | Pearson correlation r | Day of visit | eyes | eyes |
|
|
|
| Primary | The Correlation of Corneal Thickness Measurements Between Biometric Devices. | The determination of the degree of correlation of corneal thickness measurements between various biometric devices and the Orbscan II. | Note that the iTrace, IOLMaster 500, Atlas 9000, and manual caliper did not measure central corneal thickness, so no central corneal thickness data were collected from these devices. | Posted | Number | 95% Confidence Interval | Pearson correlation r | Day of visit | eyes | eyes |
|
|
|
| 204 |
| 0 |
| 204 |
| 0 |
| 204 |
| EG001 | Atlas 9000 | Atlas 9000 biometer | 0 | 204 | 0 | 204 | 0 | 204 |
| EG002 | Manual Caliper | Manual Caliper | 0 | 204 | 0 | 204 | 0 | 204 |
| EG003 | IOLMaster 500 | IOLMaster 500 biometer | 0 | 204 | 0 | 204 | 0 | 204 |
| EG004 | IOLMaster 700 | IOLMaster 700 biometer | 0 | 204 | 0 | 204 | 0 | 204 |
| EG005 | iTrace | iTrace device | 0 | 204 | 0 | 204 | 0 | 204 |
| EG006 | Lenstar LS900 | Lenstar LS900 biometer | 0 | 204 | 0 | 204 | 0 | 204 |
| EG007 | Pentacam AXL Wave | Pentacam AXL Wave device | 0 | 161 | 0 | 161 | 0 | 161 |
| EG008 | Pentacam HR | Pentacam HR device | 0 | 204 | 0 | 204 | 0 | 204 |
| EG009 | Orbscan II | Orbscan II device | 0 | 204 | 0 | 204 | 0 | 204 |
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| eyes |
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| eyes |
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