N/A
Completed N=204
Assessment of Measurement Variability Across Automated Biometry Devices
Source: ClinicalTrials.gov NCT06045325 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: The Correlation of White-to-white Measurements Between Biometric Devices. — 0.89; 0.65; 0.53; 0.60 Pearson correlation r
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Correlation of White-to-white Measurements Between Biometric Devices. |
0.89; 0.65; 0.53; 0.60; 0.82; 0.78 | — |
| PRIMARY The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices. |
0.91; 0.39; 0.33; 0.41; 0.95; 0.96 | — |
| PRIMARY The Correlation of Corneal Thickness Measurements Between Biometric Devices. |
0.82; 0.80; 0.68; 0.68; 0.73 | — |
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT06045325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.