Zonule of Zinn AbnormalityNCT05657951
Repeatability and Reproducibility of Lens Zonule Length Measurement Using ArcScan Insight 100
An observational study of Zonule of Zinn Abnormality and Zonular Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the intra-examiner repeatability and inter-examiner reproducibility in lens zonule length measurements using very high-frequency (VHF) digital ultrasound (ArcScan Insight 100). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Zonule of Zinn Abnormality, Zonular Cataract
- What is being tested?
- ArcScan Insight 100 very high-frequency digital ultrasound
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy subjects with no ocular disease except ametropia
Who may be able to join
- Subjects with no ocular disease except ametropia
- Subjects will be able to understand and willing to sign an informed consent
Who cannot join
- Previous ocular surgery
- Subjects not being able to tolerate or not willing to use pilocarpine eye drops
- Subjects has active ocular infection or inflammation
- Subjects not being able to look steadily
- Subjects not being able to open eyes wide in sterile saline even after topical anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repeatability and Reproducibility of Lens Zonule Length Measurement Using ArcScan Insight 100 Very High-frequency Digital Ultrasound
The purpose of this study is to evaluate the intra-examiner repeatability and inter-examiner reproducibility in lens zonule length measurements using very high-frequency (VHF) digital ultrasound (ArcScan Insight 100).
- Conditions
- Zonule of Zinn Abnormality, Zonular Cataract
- Being tested
- ArcScan Insight 100 very high-frequency digital ultrasound
- Medical subject headings
- Cataract, zonular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArcScan Insight 100 very high-frequency digital ultrasoundDevice
The Insight-100 (ArcScan Inc., Golden, CO, USA) employs the high-frequency B-scan in the assessment of anterior segment parameters. Anormal saline coupling medium is formed with a disposable eyepiece between the 50 MHz transducer and the eye. The instrument moves the transducer in an arc so that the beam axis maintains approximate normality to the surface of the eye. The frequencies of cornea, anterior chamber, and lens are 60 MHz, 50 MHz and 50 MHz, respectively. The maximum arc scanning range is 70 degrees, and there is a linear scanning range of 29mm. The axial and lateral resolutions are 35 μm and 65 μm, respectively. It can measure structures behind the iris, including lens zonule.
| Study group | Role | What they receive |
|---|---|---|
| Normal eyes | Not described Receives: Device: ArcScan Insight 100 very high-frequency digital ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability of ArcScan Insight 100 zonule scans in normal eyes (standard deviation and coefficient of variation)
First, three images will be obtained under'capsule model'using ArcScan Insight 100, and the length of zonule will be measured with built-in software by operator A.
Operator B then performed the measurements using the same procedure and technique.
The standard deviation and coefficient of variation of 3 repeated measurements for zonule length. will be calculated.
Measured: 1 day
Reproducibility of ArcScan Insight 100 zonule scans in normal eyes
First, three images will be obtained under'capsule model'using ArcScan Insight 100, and the length of zonule will be measured with built-in software by operator A.
Operator B then performed the measurements using the same procedure and technique.
The intraclass correlation is used to evaluate the difference between operator A and operator B.
Measured: 1 day
Secondary outcomes (1)
Repeatability of zonule length measurement with the built-in software (the intraclass correlation)
After a 1-month period, operator A and operator B will measure the zonule length again. The intraclass correlation is used to evaluate the difference between the two repeated measurements of one same image by Operator A or Operator B.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Aug 2022
- Primary completion1 Oct 2022
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Zonule of Zinn AbnormalityStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657951
- Sponsor's protocol ID
- Insight100-zonule1
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Chang P, Li Z, Qian S, Zhu Z, Wang Q, Yun-E Z. Agreement between anterior segment parameters obtained by a new ultrasound biomicroscopy and a swept-source fourier-domain anterior segment optical coherence tomography. Expert Rev Med Devices. 2020 Dec;17(12):1333-1340. doi: 10.1080/17434440.2020.1848541. Epub 2020 Dec 1.
PubMed 33196325Zhu Z, Zou H, Li H, Wu X, Wang Y, Li Z, Zhao Y. Repeatability and reproducibility of anterior lens zonule length measurement using ArcScan insight 100 very high-frequency ultrasound. Expert Rev Med Devices. 2023 Jul-Dec;20(8):703-710. doi: 10.1080/17434440.2023.2223967. Epub 2023 Jun 13.
PubMed 37300312
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Reproducibility of Lens Zonule Length Measurement Using ArcScan Insight 100 Very High-frequency Digital Ultrasound
- ClinicalTrials.gov ID
- NCT05657951
- Acronym / sponsor ID
- Insight100-zonule1
- Conditions
- Zonule of Zinn Abnormality, Zonular Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the intra-examiner repeatability and inter-examiner reproducibility in lens zonule length measurements using very high-frequency (VHF) digital ultrasound (ArcScan Insight 100).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal eyes | – | Device: ArcScan Insight 100 very high-frequency digital ultrasound |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy subjects with no ocular disease except ametropia
Key inclusion criteria (2 listed)
- Subjects with no ocular disease except ametropia
- Subjects will be able to understand and willing to sign an informed consent
Key exclusion criteria (5 listed)
- Previous ocular surgery
- Subjects not being able to tolerate or not willing to use pilocarpine eye drops
- Subjects has active ocular infection or inflammation
- Subjects not being able to look steadily
- Subjects not being able to open eyes wide in sterile saline even after topical anesthesia
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 |
|---|---|---|
| ArcScan Insight 100 very high-frequency digital ultrasoundThe Insight-100 (ArcScan Inc., Golden, CO, USA) employs the high-frequency B-scan in the assessment of anterior segment parameters. Anormal saline coupling medium is formed with a disposable eyepiece between the 50 MHz transducer and the eye. The instrument moves the transducer in an arc so that the beam axis maintains approximate normality to the surface of the eye. The frequencies of cornea, anterior chamber, and lens are 60 MHz, 50 MHz and 50 MHz, respectively. The maximum arc scanning range is 70 degrees, and there is a linear scanning range of 29mm. The axial and lateral resolutions are 35 μm and 65 μm, respectively. It can measure structures behind the iris, including lens zonule. | Device | Normal eyes |
Primary outcome
Repeatability of ArcScan Insight 100 zonule scans in normal eyes (standard deviation and coefficient of variation)
Time frame: 1 day
First, three images will be obtained under'capsule model'using ArcScan Insight 100, and the length of zonule will be measured with built-in software by operator A. Operator B then performed the measurements using the same procedure and technique. The standard deviation and coefficient of variation of 3 repeated measurements for zonule length. will be calculated.
Reproducibility of ArcScan Insight 100 zonule scans in normal eyes
Time frame: 1 day
First, three images will be obtained under'capsule model'using ArcScan Insight 100, and the length of zonule will be measured with built-in software by operator A. Operator B then performed the measurements using the same procedure and technique. The intraclass correlation is used to evaluate the difference between operator A and operator B.
1 secondary outcome
Repeatability of zonule length measurement with the built-in software (the intraclass correlation)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Background: PubMed 33196325Li X, Chang P, Li Z, Qian S, Zhu Z, Wang Q, Yun-E Z. Agreement between anterior segment parameters obtained by a new ultrasound biomicroscopy and a swept-source fourier-domain anterior segment optical coherence tomography. Expert Rev Med Devices. 2020 Dec;17(12):1333-1340. doi: 10.1080/17434440.2020.1848541. Epub 2020 Dec 1.
- Derived from this study: PubMed 37300312Zhu Z, Zou H, Li H, Wu X, Wang Y, Li Z, Zhao Y. Repeatability and reproducibility of anterior lens zonule length measurement using ArcScan insight 100 very high-frequency ultrasound. Expert Rev Med Devices. 2023 Jul-Dec;20(8):703-710. doi: 10.1080/17434440.2023.2223967. Epub 2023 Jun 13.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Zonule of Zinn Abnormality and Zonular Cataract, run by Wenzhou Medical University at 1 site in China.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Dec 2022. 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 China. 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?
Results are not available in the source record.
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?
Repeatability of ArcScan Insight 100 zonule scans in normal eyes (standard deviation and coefficient of variation) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657951, which also lists 2 linked publications.
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 20 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.