Assessment of Measurement Variability Across Automated Biometry Devices

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Measurement Variability Across Automated Biometry Devices

Conditions
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Myopia

Intervention / Treatment
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* Diagnostic Test: Orbscan II
* Diagnostic Test: IOL Master 700
* Diagnostic Test: IOL Master 500
* Diagnostic Test: Atlas 9000
* Diagnostic Test: Lenstar 900
* Diagnostic Test: Pentacam
* Diagnostic Test: iTrace
* Diagnostic Test: Argos
* Diagnostic Test: Manual caliper measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ages 18-50 years of age with healthy eyes and no prior ocular surgery At least -1.00 of myopia (spherical equivalent) Able to comprehend and willing to sign informed consent and consent and complete all required testing procedures Clear intraocular media Exclusion Criteria: 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 History of or current retinal conditions or predisposition to retinal conditions Amblyopia or strabismus in either eye History of or current anterior or posterior segment inflammation of any etiology Any form of neovascularization on or within the eye Glaucoma (uncontrolled or controlled with medication) Optic nerve atrophy Subjects with diagnosed degenerative eye disorders 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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myopic -1.00D<br>Myopic patients with a diopter of at least -1.00 | Diagnostic Test: Orbscan II<br>* Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.<br>Diagnostic Test: IOL Master 700<br>* Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.<br>Diagnostic Test: IOL Master 500<br>* Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.<br>Diagnostic Test: Atlas 9000<br>* Diagnostic assessment to measure white-to-white.<br>Diagnostic Test: Lenstar 900<br>* Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.<br>Diagnostic Test: Pentacam<br>* Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.<br>Diagnostic Test: iTrace<br>* Diagnostic assessment to measure white-to-white and corneal thickness.<br>Diagnostic Test: Argos<br>* Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.<br>Diagnostic Test: Manual caliper measurement<br>* Manual diagnostic assessment to measure white-to-white.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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. | 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. | Day of visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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-1.00 Diopter Spherical Equivalent