Myopia
Conditions
Keywords
-1.00 Diopter Spherical Equivalent
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTOrbscan II
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TESTIOL Master 700
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TESTIOL Master 500
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TESTAtlas 9000
Diagnostic assessment to measure white-to-white.
DIAGNOSTIC_TESTLenstar 900
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TESTPentacam
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TESTiTrace
Diagnostic assessment to measure white-to-white and corneal thickness.
DIAGNOSTIC_TESTArgos
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
DIAGNOSTIC_TESTManual caliper measurement
Manual diagnostic assessment to measure white-to-white.
Sponsors
Berkeley Eye Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults ages 18-50 years of age with healthy eyes and no prior ocular surgery 2. At least -1.00 of myopia (spherical equivalent) 3. Able to comprehend and willing to sign informed consent and consent and complete all required testing procedures 4. Clear intraocular media
Exclusion criteria
1. Any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study 2. History of or current retinal conditions or predisposition to retinal conditions 3. Amblyopia or strabismus in either eye 4. History of or current anterior or posterior segment inflammation of any etiology 5. Any form of neovascularization on or within the eye 6. Glaucoma (uncontrolled or controlled with medication) 7. Optic nerve atrophy 8. Subjects with diagnosed degenerative eye disorders 9. Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. connective tissue disease, immunocompromised, clinically significant atopic disease, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Correlation of White-to-white Measurements Between Biometric Devices. | Day of visit | The determination of the degree of correlation of white-to-white measurements between various biometric devices and the Orbscan II. |
| The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. | Day of visit | The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices and the Orbscan II. |
| The Correlation of Corneal Thickness Measurements Between Biometric Devices. | Day of visit | The determination of the degree of correlation of corneal thickness measurements between various biometric devices and the Orbscan II. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 204 |
| 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. | 408 |
| Total | 612 |
Baseline characteristics
| Characteristic | Myopic -1.00D |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 204 Participants |
| Sex/Gender, Customized Not disclosed | 204 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 161 | 0 / 204 | 0 / 204 |
| other Total, other adverse events | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 161 | 0 / 204 | 0 / 204 |
| serious Total, serious adverse events | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 204 | 0 / 161 | 0 / 204 | 0 / 204 |
Outcome results
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.
Time frame: Day of visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argos | The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. | 0.91 Pearson correlation r |
| Atlas 9000 | The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. | 0.39 Pearson correlation r |
| Manual Caliper | The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. | 0.33 Pearson correlation r |
| IOLMaster 500 | The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. | 0.41 Pearson correlation r |
| IOLMaster 700 | The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. | 0.95 Pearson correlation r |
| iTrace | The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. | 0.96 Pearson correlation r |
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.
Time frame: Day of visit
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argos | The Correlation of Corneal Thickness Measurements Between Biometric Devices. | 0.82 Pearson correlation r |
| Atlas 9000 | The Correlation of Corneal Thickness Measurements Between Biometric Devices. | 0.80 Pearson correlation r |
| Manual Caliper | The Correlation of Corneal Thickness Measurements Between Biometric Devices. | 0.68 Pearson correlation r |
| IOLMaster 500 | The Correlation of Corneal Thickness Measurements Between Biometric Devices. | 0.68 Pearson correlation r |
| IOLMaster 700 | The Correlation of Corneal Thickness Measurements Between Biometric Devices. | 0.73 Pearson correlation r |
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.
Time frame: Day of visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argos | The Correlation of White-to-white Measurements Between Biometric Devices. | 0.89 Pearson correlation r |
| Atlas 9000 | The Correlation of White-to-white Measurements Between Biometric Devices. | 0.65 Pearson correlation r |
| Manual Caliper | The Correlation of White-to-white Measurements Between Biometric Devices. | 0.53 Pearson correlation r |
| IOLMaster 500 | The Correlation of White-to-white Measurements Between Biometric Devices. | 0.60 Pearson correlation r |
| IOLMaster 700 | The Correlation of White-to-white Measurements Between Biometric Devices. | 0.82 Pearson correlation r |
| iTrace | The Correlation of White-to-white Measurements Between Biometric Devices. | 0.78 Pearson correlation r |
| Lenstar LS900 | The Correlation of White-to-white Measurements Between Biometric Devices. | 0.87 Pearson correlation r |
| Pentacam AXL Wave | The Correlation of White-to-white Measurements Between Biometric Devices. | 0.84 Pearson correlation r |
| Pentacam HR | The Correlation of White-to-white Measurements Between Biometric Devices. | 0.84 Pearson correlation r |