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CompletedNCT06045325Updated May 13, 2025Results posted

Assessment of Measurement Variability Across Automated Biometry Devices

An observational study in Myopia, sponsored by Berkeley Eye Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Berkeley Eye Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
204
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myopia

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Keywords

  • -1.00 Diopter Spherical Equivalent
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.)
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
204 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testOrbscan II

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

  • Diagnostic testIOL Master 700

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

  • Diagnostic testIOL Master 500

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

  • Diagnostic testAtlas 9000

    Diagnostic assessment to measure white-to-white.

  • Diagnostic testLenstar 900

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

  • Diagnostic testPentacam

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

  • Diagnostic testiTrace

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

  • Diagnostic testArgos

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

  • Diagnostic testManual caliper measurement

    Manual diagnostic assessment to measure white-to-white.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day of visit

  2. 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.

    Time frame: Day of visit

  3. 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.

    Time frame: Day of visit

06

Results

Posted May 13, 2025

Participant flow

Participant flow — Overall Study
MilestoneMyopic -1.00D
Started204
Completed204
Not completed0

Outcome measures

PrimaryThe 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.

Time frame:
Day of visit
Reported as:
Number · Pearson correlation r
The Correlation of White-to-white Measurements Between Biometric Devices.
Pearson correlation rArgosAtlas 9000Manual CaliperIOLMaster 500IOLMaster 700iTraceLenstar LS900Pentacam AXL WavePentacam HR
The Correlation of White-to-white Measurements Between Biometric Devices.0.89 (0.87 to 0.91)0.65 (0.59 to 0.71)0.53 (0.46 to 0.60)0.60 (0.54 to 0.66)0.82 (0.78 to 0.85)0.78 (0.74 to 0.82)0.87 (0.84 to 0.89)0.84 (0.81 to 0.87)0.84 (0.81 to 0.87)
PrimaryThe 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.

Time frame:
Day of visit
Reported as:
Number · Pearson correlation r
The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices.
Pearson correlation rArgosIOLMaster 500IOLMaster 700Lenstar LS900Pentacam AXL WavePentacam HR
The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices.0.91 (0.90 to 0.93)0.39 (0.31 to 0.47)0.33 (0.24 to 0.41)0.41 (0.33 to 0.49)0.95 (0.94 to 0.96)0.96 (0.96 to 0.97)
PrimaryThe 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.

Time frame:
Day of visit
Reported as:
Number · Pearson correlation r
The Correlation of Corneal Thickness Measurements Between Biometric Devices.
Pearson correlation rArgosIOLMaster 700Lenstar LS900Pentacam AXL WavePentacam HR
The Correlation of Corneal Thickness Measurements Between Biometric Devices.0.82 (0.78 to 0.85)0.80 (0.76 to 0.83)0.68 (0.63 to 0.73)0.68 (0.62 to 0.73)0.73 (0.68 to 0.77)

Adverse events

Collected over Day of visit. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Argos0/204 (0%)0/204 (0%)0/204 (0%)
Atlas 90000/204 (0%)0/204 (0%)0/204 (0%)
Manual Caliper0/204 (0%)0/204 (0%)0/204 (0%)
IOLMaster 5000/204 (0%)0/204 (0%)0/204 (0%)
IOLMaster 7000/204 (0%)0/204 (0%)0/204 (0%)
iTrace0/204 (0%)0/204 (0%)0/204 (0%)
Lenstar LS9000/204 (0%)0/204 (0%)0/204 (0%)
Pentacam AXL Wave0/161 (0%)0/161 (0%)0/161 (0%)
Pentacam HR0/204 (0%)0/204 (0%)0/204 (0%)
Orbscan II0/204 (0%)0/204 (0%)0/204 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Myopic -1.00D
<=18 years0
Between 18 and 65 years204
>=65 years0
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Myopic -1.00D
Not disclosed204
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Myopic -1.00D
07

Study locations

1 site
  • Berkeley Eye Center
    Houston, Texas 77027, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 17, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT06045325
Lead sponsor
Berkeley Eye Center
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Jul 25, 2023
Primary completion
Feb 16, 2024
Completion
Feb 16, 2024
Results posted
May 13, 2025
Last update
May 13, 2025

Study contacts

Morgan Micheletti, MD
principal investigator · Berkeley Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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