Agreement and Precision Study of UNITY® DX and a Comparator Biometer
NCT ID: NCT06826599
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2025-01-18
2025-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1 - Normal Eyes
The eye will be imaged up to seven times with the biometer to achieve three acceptable scans
Investigational Biometer
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters
IOLMaster 700 Biometer
Commercially available non-contact instrument used to capture optical biometry measurements
Group 2 - Eyes with cataracts
The eye will be imaged up to seven times with the biometer to achieve three acceptable scans
Investigational Biometer
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters
IOLMaster 700 Biometer
Commercially available non-contact instrument used to capture optical biometry measurements
Group 3 - Eyes with significant refractive errors
The eye will be imaged up to seven times with the biometer to achieve three acceptable scans
Investigational Biometer
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters
IOLMaster 700 Biometer
Commercially available non-contact instrument used to capture optical biometry measurements
Group 4 - Eyes with abnormal corneal topography
The eye will be imaged up to seven times with the biometer to achieve three acceptable scans
Investigational Biometer
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters
IOLMaster 700 Biometer
Commercially available non-contact instrument used to capture optical biometry measurements
Interventions
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Investigational Biometer
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and measurement of anterior segment and biometric parameters
IOLMaster 700 Biometer
Commercially available non-contact instrument used to capture optical biometry measurements
Eligibility Criteria
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Inclusion Criteria
* Willing and able to attend all scheduled study visits as required by the protocol.
* Identified by the investigator as eligible for at least one of the 4 eye groups identified in the protocol.
Exclusion Criteria
* Any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
* Active ocular infection or inflammation.
* Rigid or contact lens wear during the previous two weeks prior to Screening.
22 Years
ALL
Yes
Sponsors
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Cylite Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Arnold Ouyang, PhD
Role: STUDY_DIRECTOR
Cylite Pty Ltd
Locations
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NorthEast Eye Research Associates LLC
Woburn, Massachusetts, United States
Countries
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Other Identifiers
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CYC-CL-SOP-004
Identifier Type: -
Identifier Source: org_study_id
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