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Assessment of Measurement Variability Across Automated Biometry Devices

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ClinicalTrials.gov Identifier: NCT06045325
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Berkeley Eye Center

Study Description
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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.

Condition or disease Intervention/treatment
Myopia 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

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.
Study Design
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Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of Measurement Variability Across Automated Biometry Devices
Actual Study Start Date : July 25, 2023
Actual Primary Completion Date : February 16, 2024
Actual Study Completion Date : February 16, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Myopic -1.00D
Myopic patients with a diopter of at least -1.00
 Diagnostic Test: Orbscan II
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

Diagnostic Test: IOL Master 700
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

Diagnostic Test: IOL Master 500
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

Diagnostic Test: Atlas 9000
Diagnostic assessment to measure white-to-white.

Diagnostic Test: Lenstar 900
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

Diagnostic Test: Pentacam
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

Diagnostic Test: iTrace
Diagnostic assessment to measure white-to-white and corneal thickness.

Diagnostic Test: Argos
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.

Diagnostic Test: Manual caliper measurement
Manual diagnostic assessment to measure white-to-white.


Outcome Measures
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Primary Outcome Measures :
  1. The correlation of white-to-white measurements between biometric devices. [ Time Frame: Day of visit ]
    The determination of the degree of correlation of white-to-white measurements between various biometric devices.

  2. The correlation of anterior chamber depth measurements between biometric devices. [ Time Frame: Day of visit ]
    The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices.

  3. The correlation of corneal thickness measurements between biometric devices. [ Time Frame: Day of visit ]
    The determination of the degree of correlation of corneal thickness measurements between various biometric devices.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Myopic patients with a spherical equivalent of at least -1.00D with healthy eyes and no prior eye surgery.
Criteria

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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045325


Locations
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United States, Texas
Berkeley Eye Center
Houston, Texas, United States, 77027
Sponsors and Collaborators
Berkeley Eye Center
Investigators
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Principal Investigator: Morgan Micheletti, MD Berkeley Eye Center
More Information
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Responsible Party: Berkeley Eye Center
ClinicalTrials.gov Identifier: NCT06045325    
Other Study ID Numbers: BEC006
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Berkeley Eye Center:
-1.00 Diopter Spherical Equivalent
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases