Cataract SenileNCT04255706
Repeatability in Measurements of Two ssOCT and One OLCR Biometer
A study testing biometric measurement IOLMaster 700, biometric measurement Lenstar LS 700 and biometric measurement Anterion Heildelberg in people with Cataract Senile, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- biometric measurement IOLMaster 700, biometric measurement Lenstar LS 700 and biometric measurement Anterion Heildelberg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 25 Nov 2019to 1 Apr 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years old or above
- age-related cataract
Who cannot join
- patients with dense cataract or corneal pathology that would significantly influence biometric measurements
- nystagmus or pathologies that would affect patient fixation
- pregnancy- for women in reproductive age a pregnancy test will be performed.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
About this study
Official title: Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer
Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one.
Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR device.
Read the detailed description
Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome.
ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration.
This a prospective observational study that would include patients which attended pre-surgical examination. A written informed consent will be obtained from each patient.
Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Lenstar LS 700 and Anterion Heildelberg). Each patient will be measured three times with each device and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.
- Conditions
- Cataract Senile
- Being tested
- biometric measurement IOLMaster 700, biometric measurement Lenstar LS 700, biometric measurement Anterion Heildelberg
- Keywords
- ss-OCT, OLCR, biometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biometric measurement IOLMaster 700Device
Three biometric measurements will be performed with 3 devices for all the patients included
biometric measurement Lenstar LS 700Device
Three biometric measurements will be performed with 3 devices for all the patients included
biometric measurement Anterion HeildelbergDevice
Three biometric measurements will be performed with 3 devices for all the patients included
| Study group | Role | What they receive |
|---|---|---|
| Biometric measurement repeatability | Other | Biometric measurements will be performed in all patients Receives: Device: biometric measurement IOLMaster 700; Device: biometric measurement Lenstar LS 700; Device: biometric measurement Anterion Heildelberg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of repeatability between two ss-OCT and one OLCR biometry device
Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between two ss-OCT and the OLCR biometry device will be calculated for all the parameters (axial length, keratometry, anterior chamber depth, lens thickness)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start25 Nov 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract SenileStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prof, Principal investigator, VIROS, Hanusch Hospital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255706
- Sponsor's protocol ID
- ANT
- Status last verified
- Sep 2020
- First submitted
- 31 Jan 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisus AD, Hirnschall ND, Ruiss M, Pilwachs C, Georgiev S, Findl O. Repeatability of 2 swept-source OCT biometers and 1 optical low-coherence reflectometry biometer. J Cataract Refract Surg. 2021 Oct 1;47(10):1302-1307. doi: 10.1097/j.jcrs.0000000000000633.
PubMed 33770018
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer
- ClinicalTrials.gov ID
- NCT04255706
- Acronym / sponsor ID
- ANT
- Conditions
- Cataract Senile
- Keywords
- ss-OCT, OLCR, biometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 5 Feb 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.
Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one.
Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR device.
Detailed description
Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome.
ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration.
This a prospective observational study that would include patients which attended pre-surgical examination. A written informed consent will be obtained from each patient.
Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Lenstar LS 700 and Anterion Heildelberg). Each patient will be measured three times with each device and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biometric measurement repeatability | Other | Device: biometric measurement IOLMaster 700, Device: biometric measurement Lenstar LS 700, Device: biometric measurement Anterion HeildelbergBiometric measurements will be performed in all patients |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40 years old or above
- age-related cataract
Key exclusion criteria (3 listed)
- patients with dense cataract or corneal pathology that would significantly influence biometric measurements
- nystagmus or pathologies that would affect patient fixation
- pregnancy- for women in reproductive age a pregnancy test will be performed.
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 |
|---|---|---|
| biometric measurement IOLMaster 700Three biometric measurements will be performed with 3 devices for all the patients included | Device | Biometric measurement repeatability |
| biometric measurement Lenstar LS 700Three biometric measurements will be performed with 3 devices for all the patients included | Device | Biometric measurement repeatability |
| biometric measurement Anterion HeildelbergThree biometric measurements will be performed with 3 devices for all the patients included | Device | Biometric measurement repeatability |
Primary outcome
Evaluation of repeatability between two ss-OCT and one OLCR biometry device
Time frame: 8 months
Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between two ss-OCT and the OLCR biometry device will be calculated for all the parameters (axial length, keratometry, anterior chamber depth, lens thickness)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Derived from this study: PubMed 33770018Fisus AD, Hirnschall ND, Ruiss M, Pilwachs C, Georgiev S, Findl O. Repeatability of 2 swept-source OCT biometers and 1 optical low-coherence reflectometry biometer. J Cataract Refract Surg. 2021 Oct 1;47(10):1302-1307. doi: 10.1097/j.jcrs.0000000000000633.
- 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.
Oliver Findl, Prof principal investigator
VIROS, Hanusch Hospital 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 biometric measurement IOLMaster 700, biometric measurement Lenstar LS 700 and biometric measurement Anterion Heildelberg in people with Cataract Senile, run by Prim. Prof. Dr. Oliver Findl, MBA 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 3 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: finished, as of the sponsor's last update on 1 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of repeatability between two ss-OCT and one OLCR biometry device (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04255706, which also lists 1 linked publication.
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 1 Oct 2020.