CataractComparisonNCT04323358
Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract
A study testing Biometry and Keratometry in people with Cataract and Cornea, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- What is being tested?
- Biometry and Keratometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 5 Mar 2020to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related cataract
- Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna Allgemeines Krankenhaus
Vienna, 1090
Rupert Menapace, Prof., 014040066300, rupert.menapace@meduniwien.ac.at
Christina Leydolt, MD, 01 40400 ext. 79480, christina.leydolt@meduniwien.ac.at
About this study
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.
Read more
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
Read the 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.
- Being tested
- Biometry, Keratometry
- Medical subject headings
- Cataract, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiometryDiagnostic 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.
KeratometryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| IOL Master® 700 | Active comparator | Biometry will be performed three times consecutively. Receives: Diagnostic Test: Biometry; Diagnostic Test: Keratometry |
| Pentacam® | Active comparator | Keratometry will be performed three times consecutively. Receives: Diagnostic Test: Keratometry |
| Casia II® | Active comparator | Keratometry will be performed three times consecutively. Receives: Diagnostic Test: Keratometry |
| Spectralis Anterion® | Active comparator | Biometry will be performed three times consecutively. Receives: Diagnostic Test: Biometry; Diagnostic Test: Keratometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (6)
Agreement of the four devices measuring mean steep keratometry value.
The measured steep K-Value of each device and the steep k-values within one device will be compared
Measured: 1 year
Agreement of the four devices measuring mean flat keratometry value.
The measured flat K-Value of each device and the flat k-values within one device will be compared
Measured: 1 year
Agreement of the four devices measuring mean true keratometry value.
The measured true K-Value of each device and the true k-values within one device will be compared
Measured: 1 year
Agreement of the devices measuring mean axial length
The measured axial length of each device and the axial length within one device will be compared
Measured: 1 year
Agreement of the devices measuring mean lens thickness
The measured lens thickness of each device and the measured lens thickness within one device will be compared
Measured: 1 year
Agreement of the devices measuring mean white-to-white measurement
The measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start5 Mar 2020
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
- Investigators
- Rupert Menapace, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323358
- Sponsor's protocol ID
- 1845/2019
- Acronym
- Comparison
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract
- ClinicalTrials.gov ID
- NCT04323358
- Acronym / sponsor ID
- Comparison / 1845/2019
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IOL Master® 700 | Active comparator | Diagnostic Test: Biometry, Diagnostic Test: KeratometryBiometry will be performed three times consecutively. |
| Pentacam® | Active comparator | Diagnostic Test: KeratometryKeratometry will be performed three times consecutively. |
| Casia II® | Active comparator | Diagnostic Test: KeratometryKeratometry will be performed three times consecutively. |
| Spectralis Anterion® | Active comparator | Diagnostic Test: Biometry, Diagnostic Test: KeratometryBiometry will be performed three times consecutively. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age-related cataract
- Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiometryPatients 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 test | IOL Master® 700, Spectralis Anterion® |
| KeratometryPatients 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 test | Casia II®, IOL Master® 700, Pentacam®, Spectralis Anterion® |
Primary outcome
Agreement of the four devices measuring mean keratometry value.
Time frame: 1 year
The measured K-Value of each device and the k-values within one device will be compared
6 secondary outcomes
Agreement of the four devices measuring mean steep keratometry value.
Time frame: 1 year
Agreement of the four devices measuring mean flat keratometry value.
Time frame: 1 year
Agreement of the four devices measuring mean true keratometry value.
Time frame: 1 year
Agreement of the devices measuring mean axial length
Time frame: 1 year
Agreement of the devices measuring mean lens thickness
Time frame: 1 year
Agreement of the devices measuring mean white-to-white measurement
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupert Menapace, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biometry and Keratometry in people with Cataract and Cornea, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronika Röggla, MD (01 40400 ext. 79450, veronika.roeggla@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of the four devices measuring mean keratometry value. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.