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Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract

Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04323358
Acronym
Comparison
Enrollment
50
Registered
2020-03-26
Start date
2020-03-05
Completion date
2020-07-30
Last updated
2020-03-26

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

Conditions

Cataract, Cornea, Surgery

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTBiometry

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.

DIAGNOSTIC_TESTKeratometry

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.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Which eye as well as the order of devices and observer will be randomized. Randomization information will be put in a sealed envelope on screening date and opened right before measurements start.

Eligibility

Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Agreement of the four devices measuring mean keratometry value.1 yearThe measured K-Value of each device and the k-values within one device will be compared

Secondary

MeasureTime frameDescription
Agreement of the four devices measuring mean flat keratometry value.1 yearThe measured flat K-Value of each device and the flat k-values within one device will be compared
Agreement of the four devices measuring mean true keratometry value.1 yearThe measured true K-Value of each device and the true k-values within one device will be compared
Agreement of the four devices measuring mean steep keratometry value.1 yearThe measured steep K-Value of each device and the steep k-values within one device will be compared
Agreement of the devices measuring mean lens thickness1 yearThe measured lens thickness of each device and the measured lens thickness within one device will be compared
Agreement of the devices measuring mean white-to-white measurement1 yearThe measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared
Agreement of the devices measuring mean axial length1 yearThe measured axial length of each device and the axial length within one device will be compared

Countries

Austria

Contacts

Primary ContactVeronika Röggla, MD
veronika.roeggla@meduniwien.ac.at01 40400
Backup ContactChristina Leydolt, MD
christina.leydolt@meduniwien.ac.at01 40400

Outcome results

None listed

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