Assessment of Measurement Variability Across Automated Biometry Devices
NCT ID: NCT06045325
Last Updated: 2025-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
204 participants
OBSERVATIONAL
2023-07-25
2024-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.)
18 Years
50 Years
ALL
Yes
Sponsors
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Berkeley Eye Center
OTHER
Responsible Party
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Principal Investigators
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Morgan Micheletti, MD
Role: PRINCIPAL_INVESTIGATOR
Berkeley Eye Center
Locations
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Berkeley Eye Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BEC006
Identifier Type: -
Identifier Source: org_study_id
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