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Repeatability in Measurements of Two ssOCT and One OLCR Biometer

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ClinicalTrials.gov Identifier: NCT04255706
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

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.


Condition or disease Intervention/treatment Phase
Cataract Senile Device: biometric measurement IOLMaster 700 Device: biometric measurement Lenstar LS 700 Device: biometric measurement Anterion Heildelberg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer
Actual Study Start Date : November 25, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Biometric measurement repeatability
Biometric measurements will be performed in all patients
Device: biometric measurement IOLMaster 700
Three biometric measurements will be performed with 3 devices for all the patients included

Device: biometric measurement Lenstar LS 700
Three biometric measurements will be performed with 3 devices for all the patients included

Device: biometric measurement Anterion Heildelberg
Three biometric measurements will be performed with 3 devices for all the patients included




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04255706


Locations
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Austria
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, Austria, 1140
Sponsors and Collaborators
Prim. Prof. Dr. Oliver Findl, MBA
Investigators
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Principal Investigator: Oliver Findl, Prof VIROS, Hanusch Hospital Vienna
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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Head of the Ophthalmology Department, and Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT04255706    
Other Study ID Numbers: ANT
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery:
ss-OCT
OLCR
biometry
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases