Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05232214 |
| Other study ID # |
Argos |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
October 1, 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Vienna Institute for Research in Ocular Surgery |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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).
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.
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
