Assessment of Measurement Variability Across Automated Biometry Devices

Berkeley Eye Center

Status

Completed

Conditions

Myopia

Treatments

Diagnostic Test: Argos

Diagnostic Test: IOL Master 500

Diagnostic Test: Pentacam

Diagnostic Test: Orbscan II

Diagnostic Test: Atlas 9000

Diagnostic Test: Lenstar 900

Diagnostic Test: iTrace

Diagnostic Test: Manual caliper measurement

Diagnostic Test: IOL Master 700

Study type

Observational

Funder types

Other

Identifiers

NCT06045325

BEC006

Details and patient eligibility

About

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.

Full 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.

Enrollment

204 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.)