Clinical trial NCT04323358: Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract
Official title: Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Cornea
Surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Agreement of the four devices measuring mean keratometry value.
timeFrame: 1 year
Secondary outcomes:
measure: Agreement of the four devices measuring mean steep keratometry value.
timeFrame: 1 year
measure: Agreement of the four devices measuring mean flat keratometry value.
timeFrame: 1 year
measure: Agreement of the four devices measuring mean true keratometry value.
timeFrame: 1 year
measure: Agreement of the devices measuring mean axial length
timeFrame: 1 year
measure: Agreement of the devices measuring mean lens thickness
timeFrame: 1 year
measure: Agreement of the devices measuring mean white-to-white measurement
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna Allgemeines Krankenhaus
Study officials:
affiliation: Medical University of Vienna
name: Rupert Menapace, MD
role: PRINCIPAL_INVESTIGATOR
References: