MyopiaNCT06045325
Assessment of Measurement Variability Across Automated Biometry Devices
An observational study of Myopia, run by Berkeley Eye Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Orbscan II, IOL Master 700 and IOL Master 500
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to 16 Feb 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Myopic patients with a spherical equivalent of at least -1.00D with healthy eyes and no prior eye surgery.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myopia
- Being tested
- Orbscan II, IOL Master 700, IOL Master 500, Atlas 9000, Lenstar 900
- Keywords
- -1.00 Diopter Spherical Equivalent
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbscan IIDiagnostic test
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
IOL Master 700Diagnostic test
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
IOL Master 500Diagnostic test
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
Atlas 9000Diagnostic test
Diagnostic assessment to measure white-to-white.
Lenstar 900Diagnostic test
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
PentacamDiagnostic test
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
iTraceDiagnostic test
Diagnostic assessment to measure white-to-white and corneal thickness.
ArgosDiagnostic test
Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness.
Manual caliper measurementDiagnostic test
Manual diagnostic assessment to measure white-to-white.
| Study group | Role | What they receive |
|---|---|---|
| Myopic -1.00D | Myopic patients with a diopter of at least -1.00 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day of visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start25 Jul 2023
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berkeley Eye Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Micheletti, MD, Principal investigator, Berkeley Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045325
- Sponsor's protocol ID
- BEC006
- Status last verified
- May 2025
- First submitted
- 14 Sep 2023
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Measurement Variability Across Automated Biometry Devices
- ClinicalTrials.gov ID
- NCT06045325
- Acronym / sponsor ID
- BEC006
- Conditions
- Myopia
- Keywords
- -1.00 Diopter Spherical Equivalent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Berkeley Eye CenterUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myopic -1.00D | – | 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 measurementMyopic patients with a diopter of at least -1.00 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Myopic patients with a spherical equivalent of at least -1.00D with healthy eyes and no prior eye surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orbscan IIDiagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. | Diagnostic test | Myopic -1.00D |
| IOL Master 700Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. | Diagnostic test | Myopic -1.00D |
| IOL Master 500Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. | Diagnostic test | Myopic -1.00D |
| Atlas 9000Diagnostic assessment to measure white-to-white. | Diagnostic test | Myopic -1.00D |
| Lenstar 900Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. | Diagnostic test | Myopic -1.00D |
| PentacamDiagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. | Diagnostic test | Myopic -1.00D |
| iTraceDiagnostic assessment to measure white-to-white and corneal thickness. | Diagnostic test | Myopic -1.00D |
| ArgosDiagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. | Diagnostic test | Myopic -1.00D |
| Manual caliper measurementManual diagnostic assessment to measure white-to-white. | Diagnostic test | Myopic -1.00D |
Primary outcome
The Correlation of White-to-white Measurements Between Biometric Devices.
Time frame: Day of visit
The determination of the degree of correlation of white-to-white measurements between various biometric devices and the Orbscan II.
The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices.
Time frame: Day of visit
The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices and the Orbscan II.
The Correlation of Corneal Thickness Measurements Between Biometric Devices.
Time frame: Day of visit
The determination of the degree of correlation of corneal thickness measurements between various biometric devices and the Orbscan II.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan Micheletti, MD principal investigator
Berkeley Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Berkeley Eye Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Correlation of White-to-white Measurements Between Biometric Devices. (time frame: Day of visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.