Assessment of Measurement Variability Across Automated Biometry Devices

NCT ID: NCT06045325

Last Updated: 2025-05-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-25

Study Completion Date

2024-02-16

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.

Conditions

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Myopia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Myopic -1.00D

Myopic patients with a diopter of at least -1.00

Orbscan II

Intervention Type DIAGNOSTIC_TEST

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

IOL Master 700

Intervention Type DIAGNOSTIC_TEST

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

IOL Master 500

Intervention Type DIAGNOSTIC_TEST

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

Atlas 9000

Intervention Type DIAGNOSTIC_TEST

Diagnostic assessment to measure white-to-white.

Lenstar 900

Intervention Type DIAGNOSTIC_TEST

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

Pentacam

Intervention Type DIAGNOSTIC_TEST

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

iTrace

Intervention Type DIAGNOSTIC_TEST

Diagnostic assessment to measure white-to-white and corneal thickness.

Argos

Intervention Type DIAGNOSTIC_TEST

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

Manual caliper measurement

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

IOL Master 700

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

Intervention Type DIAGNOSTIC_TEST

IOL Master 500

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

Intervention Type DIAGNOSTIC_TEST

Atlas 9000

Diagnostic assessment to measure white-to-white.

Intervention Type DIAGNOSTIC_TEST

Lenstar 900

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

Intervention Type DIAGNOSTIC_TEST

Pentacam

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

Intervention Type DIAGNOSTIC_TEST

iTrace

Diagnostic assessment to measure white-to-white and corneal thickness.

Intervention Type DIAGNOSTIC_TEST

Argos

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

Intervention Type DIAGNOSTIC_TEST

Manual caliper measurement

Manual diagnostic assessment to measure white-to-white.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Berkeley Eye Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BEC006

Identifier Type: -

Identifier Source: org_study_id

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