Assessment of Measurement Variability Across Automated Biometry Devices

NCT06045325 | Completed Results FDA Device

• 1 other identifier: BEC006
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

-1.00 Diopter Spherical Equivalent

Outcome Measures

Primary Outcomes (3)

• 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 and the Orbscan II.

  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 and the Orbscan II.

  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 and the Orbscan II.

  Day of visit

Study Arms (1)

Myopic -1.00D

Myopic patients with a diopter of at least -1.00

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

Interventions

Orbscan II DIAGNOSTIC_TEST

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

Myopic -1.00D

IOL Master 700 DIAGNOSTIC_TEST

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

Myopic -1.00D

IOL Master 500 DIAGNOSTIC_TEST

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

Myopic -1.00D

Atlas 9000 DIAGNOSTIC_TEST

Diagnostic assessment to measure white-to-white.

Myopic -1.00D

Lenstar 900 DIAGNOSTIC_TEST

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

Myopic -1.00D

Pentacam DIAGNOSTIC_TEST

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

Myopic -1.00D

iTrace DIAGNOSTIC_TEST

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

Myopic -1.00D

Argos DIAGNOSTIC_TEST

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

Myopic -1.00D

Manual caliper measurement DIAGNOSTIC_TEST

Manual diagnostic assessment to measure white-to-white.

Myopic -1.00D

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Berkeley Eye Center: lead

Study Sites (1)

Berkeley Eye Center

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Tetiana Huff
• Organization: Berkeley Eye Center

tetiana.huff@berkeleyeye.com

713-620-7640

Study Officials

• Morgan Micheletti, MD

  Berkeley Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: July 25, 2023
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)