Clinical trial NCT06045325: Assessment of Measurement Variability Across Automated Biometry Devices
Official title: Assessment of Measurement Variability Across Automated Biometry Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: -1.00 Diopter Spherical Equivalent
Lead sponsor: Berkeley Eye Center
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.)

Primary outcomes:
measure: The Correlation of White-to-white Measurements Between Biometric Devices.
timeFrame: Day of visit
measure: The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices.
timeFrame: Day of visit
measure: The Correlation of Corneal Thickness Measurements Between Biometric Devices.
timeFrame: Day of visit
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
Study officials:
affiliation: Berkeley Eye Center
name: Morgan Micheletti, MD
role: PRINCIPAL_INVESTIGATOR
References: