Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract (Comparison)
24. marts 2020 opdateret af: Rupert Menapace, Medical University of Vienna
The rationale of this study is to compare repeatability, reproducibility and agreement of three different AS-OCT devices and Pentacam.
The investigational devices are approved biometry and keratometry devices to perform biometric/keratometric measurements preoperatively before cataract surgery. The measurements are used to calculate the needed IOL power.
Measurements with all four devices will be performed 3 times consecutively by two trained observer. The order of the observer, the order of devices as well as the eye (left/right) is randomized.
Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry/keratometry with four different devices
Studieoversigt
Status
Ukendt
Intervention / Behandling
Detaljeret beskrivelse
The rationale of this study is to compare repeatability, reproducibility and agreement of both, AS-OCT(s) and Pentacam.
In our department three different AS-OCT devices and a HR Scheimpflug imaging device are currently in use for clinical routine to measure the cornea.
Among refractive and anterior segment surgeons, there is no preferred and accepted method for accurate measurements of the corneal curvature.
The four diagnostic tools are based on different technical and physical imaging principles and to date only limited information on their comparability exist.
One advantage of ASOCT represents faster imaging speed when compared to Scheimpflug imaging.
Thus, imaging misalignment, segmentation errors and defocus aberration can most likely be avoided by AS-OCT.
Chen et al demonstrated that HR Scheimpflug imaging measurements of CCT were systematically higher than the measurements provided by FD AS-OCT.
Further, repeatability, reproducibility and agreement of AS-OCT and Scheimpflug imaging device will be assessed during follow-up.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Vienna, Østrig, 1090
- Rekruttering
- Medical University of Vienna Allgemeines Krankenhaus
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Kontakt:
- Rupert Menapace, Prof.
- Telefonnummer: 014040066300
- E-mail: rupert.menapace@meduniwien.ac.at
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Kontakt:
- Christina Leydolt, MD
- Telefonnummer: 79480 01 40400
- E-mail: christina.leydolt@meduniwien.ac.at
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 95 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age-related cataract
- Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)
Exclusion Criteria:
- Contact lens wear within 5 days
- Pathologic changes of the cornea, eye lid or conjunctiva on slit- lamp examination
- History of corneal ocular surgery
- Microphthalmus
- Recurrent intraocular inflammation of unknown etiology
- Blind fellow eye
- Uncontrolled systemic or ocular disease
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: IOL Master® 700
Biometry will be performed three times consecutively.
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Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
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Aktiv komparator: Pentacam®
Keratometry will be performed three times consecutively.
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Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
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Aktiv komparator: Casia II®
Keratometry will be performed three times consecutively.
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Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
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Aktiv komparator: Spectralis Anterion®
Biometry will be performed three times consecutively.
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Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Agreement of the four devices measuring mean keratometry value.
Tidsramme: 1 year
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The measured K-Value of each device and the k-values within one device will be compared
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1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Agreement of the four devices measuring mean steep keratometry value.
Tidsramme: 1 year
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The measured steep K-Value of each device and the steep k-values within one device will be compared
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1 year
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Agreement of the four devices measuring mean flat keratometry value.
Tidsramme: 1 year
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The measured flat K-Value of each device and the flat k-values within one device will be compared
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1 year
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Agreement of the four devices measuring mean true keratometry value.
Tidsramme: 1 year
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The measured true K-Value of each device and the true k-values within one device will be compared
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1 year
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Agreement of the devices measuring mean axial length
Tidsramme: 1 year
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The measured axial length of each device and the axial length within one device will be compared
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1 year
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Agreement of the devices measuring mean lens thickness
Tidsramme: 1 year
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The measured lens thickness of each device and the measured lens thickness within one device will be compared
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1 year
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Agreement of the devices measuring mean white-to-white measurement
Tidsramme: 1 year
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The measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared
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1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Rupert Menapace, MD, Medical University of Vienna
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. marts 2020
Primær færdiggørelse (Forventet)
30. juli 2020
Studieafslutning (Forventet)
30. juli 2020
Datoer for studieregistrering
Først indsendt
17. marts 2020
Først indsendt, der opfyldte QC-kriterier
24. marts 2020
Først opslået (Faktiske)
26. marts 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1845/2019
Plan for individuelle deltagerdata (IPD)
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