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OpenTrials
Completed

NCT Number: NCT04255706

Repeatability in Measurements of Two ssOCT and One OLCR Biometer

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.

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Key information

Conditions

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biometric measurement IOLMaster 700

Device

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

biometric measurement Lenstar LS 700

Device

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

biometric measurement Anterion Heildelberg

Device

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

Primary outcomes

  1. Evaluation of repeatability between two ss-OCT and one OLCR biometry device

    Time frame: 8 months

    Repeatability 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)

Sponsors and collaborators

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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