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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Hanusch Hospital, Department of Ophthalmology

    Vienna, 1140

    Oliver Findl, Prof. MD, +43 1 91021 57564, office@viros.at

    Recruiting

Other trials in Austria

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 groups in NCT05232214
Study groupRoleWhat they receive
short eyesAxial length under 22.5 mm
Receives: Device: Biometry
long eyesAxial 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.

  1. Axial length

    Limits of agreement (1.96xSD) between the optical biometers for the AL (mm) data

    Measured: 8Weeks

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted9 Feb 2022
  2. Study start1 Jan 2022
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

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)
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

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.

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