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Repeatability in Measurements of Two ssOCT and One OLCR Biometer

Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04255706
Enrollment
50
Registered
2020-02-05
Start date
2019-11-25
Completion date
2020-04-01
Last updated
2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Senile

Keywords

ss-OCT, OLCR, biometry

Brief summary

Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one. Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR 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. This a prospective observational study that would include 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, Lenstar LS 700 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.

Interventions

DEVICEbiometric measurement IOLMaster 700

Three biometric measurements will be performed with 3 devices for all the patients included

DEVICEbiometric measurement Lenstar LS 700

Three biometric measurements will be performed with 3 devices for all the patients included

DEVICEbiometric measurement Anterion Heildelberg

Three biometric measurements will be performed with 3 devices for all the patients included

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* 40 years old or above * age-related cataract

Exclusion criteria

* patients with dense cataract or 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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of repeatability between two ss-OCT and one OLCR biometry device8 monthsRepeatability coefficient (within subject standard deviation - SD) and coefficient of variation between two ss-OCT and the OLCR biometry device will be calculated for all the parameters (axial length, keratometry, anterior chamber depth, lens thickness)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026