CataractNCT05232214
Comparison of Three Swept-source Optical Coherence Biometry Devices in Long and Short Eyes
An observational study of Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
The aim of the study is to compare the agreement and repeatability of ocular biometric parameters obtained using three swept-source optical coherence tomography (ss-OCT) device (Argos, IOLMaster 700 and ANTERION). Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cataract
- What is being tested?
- Biometry
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2022to 1 Oct 2023
- 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
- Adult, Older adult
Study population: age related cataract
Who may be able to join
- Written informed consent
- 21 years old or above
- age-related cataract
- AL<22.5 mm or >25.5 mm (long or short eyes)
Who cannot join
- patients with dense cataract (LOCS grading III) or mature cataract
- corneal pathology that would significantly influence biometric measurements
- nystagmus or pathologies that would affect patient fixation
- pregnancy- for women in reproductive age a pregnancy test will be performed.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Hanusch Hospital, Department of Ophthalmology
Vienna, 1140
Oliver Findl, Prof. MD, +43 1 91021 57564, office@viros.at
About this study
The aim of the study is to compare the agreement and repeatability of ocular biometric parameters obtained using three swept-source optical coherence tomography (ss-OCT) device (Argos, IOLMaster 700 and ANTERION).
This is a prospective, single centre study, that would include a number of 50 eyes of 50 patients, which attend pre-surgical examination. Three measurements per biometry device will be performed on the day of the first eye surgery. The measurements will be performed in a randomised fashion with three ss-OCT devices (IOLMaster 700, Argos and ANTERION).
Read more
Inclusion criteria are: 40 years or above, age-related cataract, 20 eyes with AL< 22.0 mm and 30 eyes with AL>25.5 mm.
Exclusion criteria are: patients with ocular or systemic pathologies that would interfere with the measurements (e.g. dense cataract, corneal pathology, nystagmus).
The main outcome of the study will be: the difference (Limits of agreement) between the devices for the following parameters: keratometry (Ks, Kf, Km), CCT (µm), ACD (mm), LT (mm), AL (mm). Secondary outcomes will be: repeatability coefficient and coefficient of variation between the three device, measurement time for each device, and the feasibility for the Argos device.
Read the detailed description
Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome.
ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration.
A previous study reported that the AL differs between adults was due mainly to the difference in vitreous cavity. The longer the AL becomes, the longer the posterior vitreous body becomes and the Argos defines the vitreous refractive index as 1.336. Therefore it is possible that the equivalent refractive index used in the IOLMaster 700 exceeds 1.336. Omoto et al. showed that the comparison of the arithmetic prediction errors between the Argos and IOLMaster 700 indicated that both biometers showed a myopic trend and the median arithmetic prediction errors were closer to zero with the Argos, the longer the AL became, this trend became more marked, suggesting that the Argos showed a significant hyperopic trend, especially with longer ALs.
This might show the advantage of using segmental refractive index instead of equivalent refractive index in longer ALs. Nevertheless, the authors did not include short eyes (<22mm) and longer AL (>32mm), thus further studies should be needed.
The aim of the study is to compare the agreement and repeatability of AL measurement using three different ssOCT devices in short (<22.5mm) and long eyes (>25.5mm).
This a prospective, randomised, observational study that would include patients (42 eyes of 42 patients) which attended pre-surgical examination. A written informed consent will be obtained from each patient.
Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Argos and Anterion Heildelberg). Each patient will be measured three times with each device and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.
The order in which the measurements will be performed (Anterion, IOLMaster 700 or Argos) will be randomised using randomised.org.
Patients will be measured 8 weeks (+/-2 weeks) postoperatively with the three devices and the postoperative examination will also contain visual acuity, autorefraction and subjective refraction.
Each patient will receive the same type of lens (standard IOL, Clareon, Alcon). Inclusion criteria
- Written informed consent
- 21 years old or above
- age-related cataract
- AL<22.5 mm or >25.5 mm (long or short eyes) Exclusion criteria
- patients with dense cataract (LOCS grading III) or mature cataract
- corneal pathology that would significantly influence biometric measurements
- nystagmus or pathologies that would affect patient fixation
- pregnancy- for women in reproductive age a pregnancy test will be performed.
- Main outcome: Limits of agreement (1.96xSD) between the optical biometers for the AL (mm) data
- Secondary outcomes:
- Subgroup analysis for the refractive outcome (SEQ) after 8 weeks (+/-2 weeks) in short (<22,5mm) and long eyes (>25,5mm).
- Limits of agreement (1.96xSD) between the optical biometers for the following variables: keratometry (Ks, Kf, Km), CCT (µm), ACD (mm), LT (mm),
- Duration (seconds) of measurement time and total time (including data entry)
- Evaluation of the Barrett (and Haigis formulae with the 3 devices (mean of actual vs. mean of predicted SEQ)
- Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between the three devices
- Conditions
- Cataract
- Being tested
- Biometry
- Keywords
- biometry
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiometryDevice
Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Argos and Anterion Heildelberg). Each patient will be measured three times with each device
| Study group | Role | What they receive |
|---|---|---|
| short eyes | Axial length under 22.5 mm Receives: Device: Biometry | |
| long eyes | Axial length under 25.5 mm Receives: Device: Biometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Limits of agreement (1.96xSD) between the optical biometers for the AL (mm) data
Measured: 8Weeks
Secondary outcomes (2)
other Biometry parameter
- Limits of agreement (1.96xSD) between the optical biometers for the following variables: keratometry (Ks, Kf, Km), CCT (µm), ACD (mm), LT (mm),
Measured: 8 weeks
Repeatability
- Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between the three devices
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Jan 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Prospective
- Enrolment
- 42 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232214
- Sponsor's protocol ID
- Argos
- Status last verified
- Oct 2022
- First submitted
- 30 Jan 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All results will be shared in a published paper
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Swept-source Optical Coherence Biometry Devices in Long and Short Eyes
- ClinicalTrials.gov ID
- NCT05232214
- Acronym / sponsor ID
- Argos
- Conditions
- Cataract
- Keywords
- biometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 9 Feb 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 aim of the study is to compare the agreement and repeatability of ocular biometric parameters obtained using three swept-source optical coherence tomography (ss-OCT) device (Argos, IOLMaster 700 and ANTERION).
This is a prospective, single centre study, that would include a number of 50 eyes of 50 patients, which attend pre-surgical examination. Three measurements per biometry device will be performed on the day of the first eye surgery. The measurements will be performed in a randomised fashion with three ss-OCT devices (IOLMaster 700, Argos and ANTERION).
Inclusion criteria are: 40 years or above, age-related cataract, 20 eyes with AL< 22.0 mm and 30 eyes with AL>25.5 mm.
Exclusion criteria are: patients with ocular or systemic pathologies that would interfere with the measurements (e.g. dense cataract, corneal pathology, nystagmus).
The main outcome of the study will be: the difference (Limits of agreement) between the devices for the following parameters: keratometry (Ks, Kf, Km), CCT (µm), ACD (mm), LT (mm), AL (mm). Secondary outcomes will be: repeatability coefficient and coefficient of variation between the three device, measurement time for each device, and the feasibility for the Argos device.
Detailed description
Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome.
ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration.
A previous study reported that the AL differs between adults was due mainly to the difference in vitreous cavity. The longer the AL becomes, the longer the posterior vitreous body becomes and the Argos defines the vitreous refractive index as 1.336. Therefore it is possible that the equivalent refractive index used in the IOLMaster 700 exceeds 1.336. Omoto et al. showed that the comparison of the arithmetic prediction errors between the Argos and IOLMaster 700 indicated that both biometers showed a myopic trend and the median arithmetic prediction errors were closer to zero with the Argos, the longer the AL became, this trend became more marked, suggesting that the Argos showed a significant hyperopic trend, especially with longer ALs.
This might show the advantage of using segmental refractive index instead of equivalent refractive index in longer ALs. Nevertheless, the authors did not include short eyes (<22mm) and longer AL (>32mm), thus further studies should be needed.
The aim of the study is to compare the agreement and repeatability of AL measurement using three different ssOCT devices in short (<22.5mm) and long eyes (>25.5mm).
This a prospective, randomised, observational study that would include patients (42 eyes of 42 patients) which attended pre-surgical examination. A written informed consent will be obtained from each patient.
Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Argos and Anterion Heildelberg). Each patient will be measured three times with each device and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.
The order in which the measurements will be performed (Anterion, IOLMaster 700 or Argos) will be randomised using randomised.org.
Patients will be measured 8 weeks (+/-2 weeks) postoperatively with the three devices and the postoperative examination will also contain visual acuity, autorefraction and subjective refraction.
Each patient will receive the same type of lens (standard IOL, Clareon, Alcon). Inclusion criteria
- Written informed consent
- 21 years old or above
- age-related cataract
- AL<22.5 mm or >25.5 mm (long or short eyes) Exclusion criteria
- patients with dense cataract (LOCS grading III) or mature cataract
- corneal pathology that would significantly influence biometric measurements
- nystagmus or pathologies that would affect patient fixation
- pregnancy- for women in reproductive age a pregnancy test will be performed.
- Main outcome: Limits of agreement (1.96xSD) between the optical biometers for the AL (mm) data
- Secondary outcomes:
- Subgroup analysis for the refractive outcome (SEQ) after 8 weeks (+/-2 weeks) in short (<22,5mm) and long eyes (>25,5mm).
- Limits of agreement (1.96xSD) between the optical biometers for the following variables: keratometry (Ks, Kf, Km), CCT (µm), ACD (mm), LT (mm),
- Duration (seconds) of measurement time and total time (including data entry)
- Evaluation of the Barrett (and Haigis formulae with the 3 devices (mean of actual vs. mean of predicted SEQ)
- Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between the three devices
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short eyes | – | Device: BiometryAxial length under 22.5 mm |
| long eyes | – | Device: BiometryAxial length under 25.5 mm |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- age related cataract
Key inclusion criteria (4 listed)
- Written informed consent
- 21 years old or above
- age-related cataract
- AL<22.5 mm or >25.5 mm (long or short eyes)
Key exclusion criteria (4 listed)
- patients with dense cataract (LOCS grading III) or mature cataract
- corneal pathology that would significantly influence biometric measurements
- nystagmus or pathologies that would affect patient fixation
- pregnancy- for women in reproductive age a pregnancy test will be performed.
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 |
|---|---|---|
| BiometryOnly one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Argos and Anterion Heildelberg). Each patient will be measured three times with each device | Device | long eyes, short eyes |
Primary outcome
Axial length
Time frame: 8Weeks
Limits of agreement (1.96xSD) between the optical biometers for the AL (mm) data
2 secondary outcomes
other Biometry parameter
Time frame: 8 weeks
Repeatability
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No. All results will be shared in a published paper
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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.
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, 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 4 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: status not confirmed, as of the sponsor's last update on 17 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 8Weeks). 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 17 Oct 2022.