HealthyNCT02377154
Comparability of Keratometry of VERION Image Guided System With Established Measuring Devices
A study testing Slit lamp, Autorefractor and IOLMaster 500 in people with Healthy, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to determine if the keratometric functions of the VERION Image Guided System are comparable to those of established keratometric devices (IOLMaster 500, Pentacam HR, LenStar LS900). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Slit lamp, Autorefractor and IOLMaster 500
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to May 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All interested individuals
- Full legal capacity
Who cannot join
- Pre-existing or actual ocular disease or pathology, history of ocular surgery
- Contact lens wear 2 weeks before examination
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of ophthalmology, University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Comparability of Keratometry and Intraocular Lens (IOL) Calculation of VERION Image Guided System With Established Measuring Devices in Ophthalmologically Healthy Individuals
The purpose of this study is to determine if the keratometric functions of the VERION Image Guided System are comparable to those of established keratometric devices (IOLMaster 500, Pentacam HR, LenStar LS900). Calculated intraocular lenses (IOLs) are compared as a clinical consequence of the biometric measurement for IOLMaster 500, LenStar LS900 and VERION Image Guided System.
In addition the comfort and duration of examination in the different devices is evaluated.
- Conditions
- Healthy
- Being tested
- Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900
- Keywords
- keratometry, verion, iol, intraocular lens, iolmaster, lenstar, pentacam, IOL calculation, VERION Image Guided System
- Medical subject headings
- Intraocular Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slit lampDevice
Examination of cornea
AutorefractorDevice
Measurement of refraction
IOLMaster 500Device
Measurement of axial length and white-to-white distance; Keratometry; IOL calculation
Pentacam HRDevice
Measurement of white-to-white distance; Keratometry
LenStar LS900Device
Measurement of axial length and white-to-white distance; Keratometry; IOL calculation
VERION Image Guided SystemDevice
Measurement of white-to-white distance; Keratometry; IOL calculation with axial length value of IOLMaster 500
| Study group | Role | What they receive |
|---|---|---|
| Opthalmologically healthy individuals | Other | Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System Receives: Device: Slit lamp; Device: Autorefractor; Device: IOLMaster 500; Device: Pentacam HR; Device: LenStar LS900; Device: VERION Image Guided System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of repeatability of keratometry as performed by VERION Image Guided System
Measured: 3 immediate repetitions at study visit (study consists of 1 visit only)
Secondary outcomes (5)
Subjective comfort for test persons as evaluated by questionnaire
Measured: Immediately after study visit (study consists of 1 visit only)
Duration of measurements of each keratometric device as taken by stopwatch
Measured: During measurements from placement of head until completion
Keratometric values as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Measured: At study visit (study consists of 1 visit only)
White-to-White distance as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Measured: At study visit (study consists of 1 visit only)
Intraocular lens calculation as performed by IOLMaster 500, LenStar LS900, VERION Image Guided System
Measured: Immediately after measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Mike P. Holzer, Heidelberg University
- Investigators
- Mike P Holzer, MD, FEBO, Principal investigator, Department of opthalmology, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377154
- Sponsor's protocol ID
- S-532/2014
- Status last verified
- Dec 2017
- First submitted
- 13 Feb 2015
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparability of Keratometry and Intraocular Lens (IOL) Calculation of VERION Image Guided System With Established Measuring Devices in Ophthalmologically Healthy Individuals
- ClinicalTrials.gov ID
- NCT02377154
- Acronym / sponsor ID
- S-532/2014
- Conditions
- Healthy
- Keywords
- keratometry, verion, iol, intraocular lens, iolmaster, lenstar, pentacam, IOL calculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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 purpose of this study is to determine if the keratometric functions of the VERION Image Guided System are comparable to those of established keratometric devices (IOLMaster 500, Pentacam HR, LenStar LS900). Calculated intraocular lenses (IOLs) are compared as a clinical consequence of the biometric measurement for IOLMaster 500, LenStar LS900 and VERION Image Guided System.
In addition the comfort and duration of examination in the different devices is evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opthalmologically healthy individuals | Other | Device: Slit lamp, Device: Autorefractor, Device: IOLMaster 500, Device: Pentacam HR, Device: LenStar LS900, Device: VERION Image Guided SystemSlit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All interested individuals
- Full legal capacity
Key exclusion criteria (2 listed)
- Pre-existing or actual ocular disease or pathology, history of ocular surgery
- Contact lens wear 2 weeks before examination
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 |
|---|---|---|
| Slit lampExamination of cornea | Device | Opthalmologically healthy individuals |
| AutorefractorMeasurement of refraction | Device | Opthalmologically healthy individuals |
| IOLMaster 500Measurement of axial length and white-to-white distance; Keratometry; IOL calculation | Device | Opthalmologically healthy individuals |
| Pentacam HRMeasurement of white-to-white distance; Keratometry | Device | Opthalmologically healthy individuals |
| LenStar LS900Measurement of axial length and white-to-white distance; Keratometry; IOL calculation | Device | Opthalmologically healthy individuals |
| VERION Image Guided SystemMeasurement of white-to-white distance; Keratometry; IOL calculation with axial length value of IOLMaster 500 | Device | Opthalmologically healthy individuals |
Primary outcome
Accuracy of repeatability of keratometry as performed by VERION Image Guided System
Time frame: 3 immediate repetitions at study visit (study consists of 1 visit only)
5 secondary outcomes
Subjective comfort for test persons as evaluated by questionnaire
Time frame: Immediately after study visit (study consists of 1 visit only)
Duration of measurements of each keratometric device as taken by stopwatch
Time frame: During measurements from placement of head until completion
Keratometric values as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Time frame: At study visit (study consists of 1 visit only)
White-to-White distance as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
Time frame: At study visit (study consists of 1 visit only)
Intraocular lens calculation as performed by IOLMaster 500, LenStar LS900, VERION Image Guided System
Time frame: Immediately after measurement
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 13 Dec 2017.
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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.
Mike P Holzer, MD, FEBO principal investigator
Department of opthalmology, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slit lamp, Autorefractor and IOLMaster 500 in people with Healthy, run by Heidelberg University at 1 site in Germany.
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 2 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 13 Dec 2017. 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 Germany. 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?
Accuracy of repeatability of keratometry as performed by VERION Image Guided System (time frame: 3 immediate repetitions at study visit (study consists of 1 visit only)). 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 13 Dec 2017.