Cataract SenileNCT04333056
Comparison Between Two Ss-OCT Biometry
An observational study of Cataract Senile, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Since recently a second swept-source optical coherence tomography (ss-OCT) optical biometry device was launched (Anterion, Heidelberg Engineering). Aim of this study is a retrospective data collection of patients who were measured with both ss-OCT optical biometry devices and to assess the limits of agreement of the… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- Biometric measurement agreement
- How many people
- 210 participants
- Where
- 1 siteAustria
- Study dates
- 14 May 2019to 12 Aug 2019
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants were selected by the clinical investigators at the Hanusch Hospital.
Who may be able to join
- age-related cataract
Who cannot join
- nystagmus
- physical inabilities that could interfere with fixation
- dens cataract
- macular or corneal pathologies that could compromise fixation during the measurements.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
About this study
Official title: Comparison of Two Swept-Source Optical Coherence Tomography-based Biometry Devices
Since recently a second swept-source optical coherence tomography (ss-OCT) optical biometry device was launched (Anterion, Heidelberg Engineering). Aim of this study is a retrospective data collection of patients who were measured with both ss-OCT optical biometry devices and to assess the limits of agreement of the two devices.
Retrospective comparison of two ss-OCT biometry devices concerning comparability of measurements of axial eye length, anterior chamber depth, lens thickness and keratometry.
Read the detailed description
This a retrospective study including data acquired from patients that attended pre-surgical examination as it is the standard in the investigator's hospital.
The IOL Master 700 (Carl Zeiss Meditec AG, Jena) and the Heidelberg Anterion (Heidelberg Engineering, Germany) are biometry devices that use swept-source optical coherence tomography technology in combination with a multidot-keratometer, that obtain two-dimensional images of ocular structures.
The difference between the two devices resides in the wavelength of the infrared laser: 1200-1400nm for the Anterion and 1050nm for the IOL Master 700.
The SS-OCT devices provide a scan depth of 44mm and a resolution in tissue of 22 μm for the IOL Master 700 and of 14x16.5 mm and 30 μm for the Heidelberg Anterion.
- Conditions
- Cataract Senile
- Being tested
- Biometric measurement agreement
- Keywords
- biometry, ss-OCT, cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biometric measurement agreementOther
Patients scheduled for cataract surgery were measured with both ss-OCT devices. The following biometry parameters were compared: anterior keratometry, central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT) and axial length (AL).
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters AL, ACD, LT (evaluated in mm)
For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution.
The student T test for paired samples and Wilcoxon for nonparametric data was used to compare parameters as: AL, ACD, LT.
The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs
Measured: 6 months
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters CCT (evaluated in micrometer)
For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution.
The student T test for paired samples and Wilcoxon for nonparametric data was used to compare the CCT data The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs
Measured: 6 months
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameter: keratometry (evaluated in diopter)
For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution.
The student T test for paired samples and Wilcoxon for nonparametric data was used to compare keratometry data The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start14 May 2019
- Primary completion31 Jul 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract SenileStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prof., MD, Principal investigator, VIROS, Hanusch Hospital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333056
- Sponsor's protocol ID
- ss-OCT biometry comparison
- Status last verified
- Mar 2020
- First submitted
- 28 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisus AD, Hirnschall ND, Findl O. Comparison of 2 swept-source optical coherence tomography-based biometry devices. J Cataract Refract Surg. 2021 Jan 1;47(1):87-92. doi: 10.1097/j.jcrs.0000000000000373.
PubMed 32769752
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Swept-Source Optical Coherence Tomography-based Biometry Devices
- ClinicalTrials.gov ID
- NCT04333056
- Acronym / sponsor ID
- ss-OCT biometry comparison
- Conditions
- Cataract Senile
- Keywords
- biometry, ss-OCT, cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 3 Apr 2020 (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.
Since recently a second swept-source optical coherence tomography (ss-OCT) optical biometry device was launched (Anterion, Heidelberg Engineering). Aim of this study is a retrospective data collection of patients who were measured with both ss-OCT optical biometry devices and to assess the limits of agreement of the two devices.
Retrospective comparison of two ss-OCT biometry devices concerning comparability of measurements of axial eye length, anterior chamber depth, lens thickness and keratometry.
Detailed description
This a retrospective study including data acquired from patients that attended pre-surgical examination as it is the standard in the investigator's hospital.
The IOL Master 700 (Carl Zeiss Meditec AG, Jena) and the Heidelberg Anterion (Heidelberg Engineering, Germany) are biometry devices that use swept-source optical coherence tomography technology in combination with a multidot-keratometer, that obtain two-dimensional images of ocular structures.
The difference between the two devices resides in the wavelength of the infrared laser: 1200-1400nm for the Anterion and 1050nm for the IOL Master 700.
The SS-OCT devices provide a scan depth of 44mm and a resolution in tissue of 22 μm for the IOL Master 700 and of 14x16.5 mm and 30 μm for the Heidelberg Anterion.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants were selected by the clinical investigators at the Hanusch Hospital.
Key inclusion criteria (1 listed)
- age-related cataract
Key exclusion criteria (4 listed)
- nystagmus
- physical inabilities that could interfere with fixation
- dens cataract
- macular or corneal pathologies that could compromise fixation during the measurements.
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 |
|---|---|---|
| Biometric measurement agreementPatients scheduled for cataract surgery were measured with both ss-OCT devices. The following biometry parameters were compared: anterior keratometry, central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT) and axial length (AL). | Other | – |
Primary outcome
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters AL, ACD, LT (evaluated in mm)
Time frame: 6 months
For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution. The student T test for paired samples and Wilcoxon for nonparametric data was used to compare parameters as: AL, ACD, LT. The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters CCT (evaluated in micrometer)
Time frame: 6 months
For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution. The student T test for paired samples and Wilcoxon for nonparametric data was used to compare the CCT data The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameter: keratometry (evaluated in diopter)
Time frame: 6 months
For descriptive analysis, Kolmogorov Smirnov test will be used to evaluate normal distribution. The student T test for paired samples and Wilcoxon for nonparametric data was used to compare keratometry data The limits of agreement (1.96xSD) between two optical biometers were calculated and represented graphically using Bland-Altman graphs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 32769752Fisus AD, Hirnschall ND, Findl O. Comparison of 2 swept-source optical coherence tomography-based biometry devices. J Cataract Refract Surg. 2021 Jan 1;47(1):87-92. doi: 10.1097/j.jcrs.0000000000000373.
- 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.
Oliver Findl, Prof., MD principal investigator
VIROS, Hanusch Hospital Vienna
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 Cataract Senile, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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 1 inclusion and 4 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 3 Apr 2020. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Limits of agreement between two optical biometers using the same SS-OCT technology for the following parameters AL, ACD, LT (evaluated in mm) (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT04333056, which also lists 1 linked publication.
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 3 Apr 2020.