CataractSTARGUSNCT05534373
Comparative STudy of the ARGos Biometer Compared to UltraSound Biometer in B-mode in Case of Measure Failure With a the Conventional Biometer
An observational study of Cataract, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Biometry has become one of the most important steps in modern cataract surgery. The axial length of the eye may be measured by ultrasound (either contact or immersion) or by optical means. Non-contact optical biometry has become the gold-standard because of its ease of use, accuracy, and reproducibility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2023to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective observational multicentre non-interventional study including patients whose measurements were performed between August 2021 and January 2022.
Who may be able to join
- Patient over 18 years of age
- All consecutive patient measured on Argos and any other conventional optical biometer and presenting a failure with one of the conventional optical biometer in AL measurement due to cataract density
Who cannot join
- Silicon tamponade in the posterior segment
- Patients who are informed and objected to participating to the research
- Patient subject to legal protection measures.
Trial locations and contacts
1 site in 1 country.
About this study
Biometry has become one of the most important steps in modern cataract surgery. The axial length of the eye may be measured by ultrasound (either contact or immersion) or by optical means.
Non-contact optical biometry has become the gold-standard because of its ease of use, accuracy, and reproducibility. However, the main disadvantage of the optical methods is their inability to obtain axial length measurements in approximately 10% of eyes, typically those with dense posterior subcapsular cataracts.
Read more
By Using SS-OCT device, it has been reported that the AL measurements cannot be made in 0.6 to 7.4% of cases . Therefore, measurement by US biometer is still necessary for advanced cataract. The ultrasound measure the LA between the corneal epithelium and the vitreomacular interface. Ultrasound in B mode (or Brilliance) with the help of the control vector allows a 2-dimensional control of the plan used for measurement. This method is used in current practice in our centers when LA measurements is not possible with our optical SS-biometer.
Recently Alcon has integrated the ARGOS® biometer's diagnostic testing with Alcon's Cataract Refractive Suite technologies. ARGOS® is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS® measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White-to-White (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. ARGOS® includes an operation mode for when the retina is hardly or not visible at all denominated the "Enhanced Retinal Visualization mode" (ERV) that allows, in most cases, visualization of the retina. This signal in the retinal region is enhanced by shifting the coherence function (Argos Users manual).
In a prospective observational study conducted in 2 centers in USA involving 107 eyes, they have evaluated the repeatability and reproducibility of ARGOS® measurements in comparison with IOLMaster®500 and LENSTAR LS 900. They have shown that the AL acquisition rate was higher with ARGOS® (96%) compared with both LENSTAR LS 900 (79%) and IOLMaster®500 (77%). The reason was that ARGOS® was more successful at measuring AL in eyes with dense cataract.
Read the detailed description
Our recent experience with Argos has shown that LA measurements were even possible with our without ERV mode in case of very dense (ie: cataracts in diabetic patients) or posterior subcapsular cataracts.
These observations lead us to propose a retrospective study to compare Argos to our gold standard "ultrasound biometer in mode B" for LA measurements in case of failure with the conventional optical biometer used in our current practice (Lenstar LS900, IOLMaster 500, 700) In current practice, the biometry measurements are conducted with our conventional optical biometer during the visit prior to cataract surgery.
At the same time, measures will be conducted on Argos with or without the ERV mode If axial length measurements are impossible with our conventional optical biometer due to the level of cataract density, axial length measurements will be conducted with our ultrasound biometer in mode-B (Quantel Medical, Aviso S with the 10MHz probe) according to our current practice.
We will retrospectively collect the consecutive data from eyes for which axial length measurements with our conventional biometer were not possible
- Conditions
- Cataract
- Keywords
- ARGOS biometer, UltraSound biometer, conventional biometer, cataract surgery
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe axial length (AL) measured by the Argos biometer in case of measure failure with a conventional optical biometer and to compare it with the AL measured with ultrasound biometry in B-mode (considered to be the gold standard)
Axial length (AL) in millimeters obtained with Argos and ultrasound biometer in B-mode scans (considered to be the reference method for dense cataract)
Measured: 2 months
Secondary outcomes (3)
to describe Pachymetry in micrometers obtained with Argos biometer, conventional biometer and ultrasound biometer
Pachymetry in micrometers obtained with Argos biometer, conventional biometer and ultrasound biometer
Measured: 2 months
to measure anterior chamber depth in millimeters obtained with Argos biometer, conventional biometer and ultrasound biometer
Anterior chamber depth in millimeters obtained with Argos biometer, conventional biometer and ultrasound biometer
Measured: 2 months
to measure lens thickness obtained with Argos biometer and ultrasound biometer
Lens thickness obtained with Argos biometer and ultrasound biometer
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study startFeb 2023 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionMay 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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534373
- Sponsor's protocol ID
- APHP220627
- Acronym
- STARGUS
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative STudy of the ARGos Biometer Compared to UltraSound Biometer in B-mode in Case of Measure Failure With a the Conventional Biometer
- ClinicalTrials.gov ID
- NCT05534373
- Acronym / sponsor ID
- STARGUS / APHP220627
- Conditions
- Cataract
- Keywords
- ARGOS biometer, UltraSound biometer, conventional biometer, cataract surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 9 Sep 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.
Biometry has become one of the most important steps in modern cataract surgery. The axial length of the eye may be measured by ultrasound (either contact or immersion) or by optical means.
Non-contact optical biometry has become the gold-standard because of its ease of use, accuracy, and reproducibility. However, the main disadvantage of the optical methods is their inability to obtain axial length measurements in approximately 10% of eyes, typically those with dense posterior subcapsular cataracts.
By Using SS-OCT device, it has been reported that the AL measurements cannot be made in 0.6 to 7.4% of cases . Therefore, measurement by US biometer is still necessary for advanced cataract. The ultrasound measure the LA between the corneal epithelium and the vitreomacular interface. Ultrasound in B mode (or Brilliance) with the help of the control vector allows a 2-dimensional control of the plan used for measurement. This method is used in current practice in our centers when LA measurements is not possible with our optical SS-biometer.
Recently Alcon has integrated the ARGOS® biometer's diagnostic testing with Alcon's Cataract Refractive Suite technologies. ARGOS® is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS® measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White-to-White (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. ARGOS® includes an operation mode for when the retina is hardly or not visible at all denominated the "Enhanced Retinal Visualization mode" (ERV) that allows, in most cases, visualization of the retina. This signal in the retinal region is enhanced by shifting the coherence function (Argos Users manual).
In a prospective observational study conducted in 2 centers in USA involving 107 eyes, they have evaluated the repeatability and reproducibility of ARGOS® measurements in comparison with IOLMaster®500 and LENSTAR LS 900. They have shown that the AL acquisition rate was higher with ARGOS® (96%) compared with both LENSTAR LS 900 (79%) and IOLMaster®500 (77%). The reason was that ARGOS® was more successful at measuring AL in eyes with dense cataract.
Detailed description
Our recent experience with Argos has shown that LA measurements were even possible with our without ERV mode in case of very dense (ie: cataracts in diabetic patients) or posterior subcapsular cataracts.
These observations lead us to propose a retrospective study to compare Argos to our gold standard "ultrasound biometer in mode B" for LA measurements in case of failure with the conventional optical biometer used in our current practice (Lenstar LS900, IOLMaster 500, 700) In current practice, the biometry measurements are conducted with our conventional optical biometer during the visit prior to cataract surgery.
At the same time, measures will be conducted on Argos with or without the ERV mode If axial length measurements are impossible with our conventional optical biometer due to the level of cataract density, axial length measurements will be conducted with our ultrasound biometer in mode-B (Quantel Medical, Aviso S with the 10MHz probe) according to our current practice.
We will retrospectively collect the consecutive data from eyes for which axial length measurements with our conventional biometer were not possible
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective observational multicentre non-interventional study including patients whose measurements were performed between August 2021 and January 2022.
Key inclusion criteria (2 listed)
- Patient over 18 years of age
- All consecutive patient measured on Argos and any other conventional optical biometer and presenting a failure with one of the conventional optical biometer in AL measurement due to cataract density
Key exclusion criteria (3 listed)
- Silicon tamponade in the posterior segment
- Patients who are informed and objected to participating to the research
- Patient subject to legal protection measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe axial length (AL) measured by the Argos biometer in case of measure failure with a conventional optical biometer and to compare it with the AL measured with ultrasound biometry in B-mode (considered to be the gold standard)
Time frame: 2 months
Axial length (AL) in millimeters obtained with Argos and ultrasound biometer in B-mode scans (considered to be the reference method for dense cataract)
3 secondary outcomes
to describe Pachymetry in micrometers obtained with Argos biometer, conventional biometer and ultrasound biometer
Time frame: 2 months
to measure anterior chamber depth in millimeters obtained with Argos biometer, conventional biometer and ultrasound biometer
Time frame: 2 months
to measure lens thickness obtained with Argos biometer and ultrasound biometer
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- 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.
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 Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 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 9 Jan 2023. 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 France. 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?
Contact Audrey GIOCANTI (01 48 95 52 18, audrey.giocanti@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe axial length (AL) measured by the Argos biometer in case of measure failure with a conventional optical biometer and to compare it with the AL measured with ultrasound biometry in B-mode (considered to be the gold standard) (time frame: 2 months). 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 9 Jan 2023.