Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract (Comparison)
24 mars 2020 mis à jour par: 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
Aperçu de l'étude
Statut
Inconnue
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Vienna, L'Autriche, 1090
- Recrutement
- Medical University of Vienna Allgemeines Krankenhaus
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Contact:
- Rupert Menapace, Prof.
- Numéro de téléphone: 014040066300
- E-mail: rupert.menapace@meduniwien.ac.at
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Contact:
- Christina Leydolt, MD
- Numéro de téléphone: 79480 01 40400
- E-mail: christina.leydolt@meduniwien.ac.at
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 95 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Comparateur actif: 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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Comparateur actif: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Agreement of the four devices measuring mean keratometry value.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Agreement of the four devices measuring mean steep keratometry value.
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Rupert Menapace, MD, Medical University of Vienna
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
5 mars 2020
Achèvement primaire (Anticipé)
30 juillet 2020
Achèvement de l'étude (Anticipé)
30 juillet 2020
Dates d'inscription aux études
Première soumission
17 mars 2020
Première soumission répondant aux critères de contrôle qualité
24 mars 2020
Première publication (Réel)
26 mars 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 mars 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 mars 2020
Dernière vérification
1 mars 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1845/2019
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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