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

NCT04323358 | Unknown DMC

• 1 other identifier: 1845/2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Cataract; Cornea; Surgery

Outcome Measures

Primary Outcomes (1)

• Agreement of the four devices measuring mean keratometry value.

  The measured K-Value of each device and the k-values within one device will be compared

  1 year

Secondary Outcomes (6)

• Agreement of the four devices measuring mean steep keratometry value.

  1 year

• Agreement of the four devices measuring mean flat keratometry value.

  1 year

• Agreement of the four devices measuring mean true keratometry value.

  1 year

• Agreement of the devices measuring mean axial length

  1 year

• Agreement of the devices measuring mean lens thickness

  1 year

Study Arms (4)

IOL Master® 700

ACTIVE COMPARATOR

Biometry will be performed three times consecutively.

Diagnostic Test: Biometry; Diagnostic Test: Keratometry

Pentacam®

ACTIVE COMPARATOR

Keratometry will be performed three times consecutively.

Diagnostic Test: Keratometry

Casia II®

ACTIVE COMPARATOR

Keratometry will be performed three times consecutively.

Diagnostic Test: Keratometry

Spectralis Anterion®

ACTIVE COMPARATOR

Biometry will be performed three times consecutively.

Diagnostic Test: Biometry; Diagnostic Test: Keratometry

Interventions

Biometry DIAGNOSTIC_TEST

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.

IOL Master® 700; Spectralis Anterion®

Keratometry DIAGNOSTIC_TEST

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.

Casia II®; IOL Master® 700; Pentacam®; Spectralis Anterion®

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age-related cataract
• Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna Allgemeines Krankenhaus

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Cataract; Corneal Diseases

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Rupert Menapace, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronika Röggla, MD

CONTACT

01 40400; veronika.roeggla@meduniwien.ac.at

Christina Leydolt, MD

CONTACT

01 40400; christina.leydolt@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 26, 2020
• Study Start: March 5, 2020
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)