CataractNCT01961089
Galilei Lens Professional vs. Predicate Devices: a Comparison Study
A study testing Galilei Lens Professional, IOLMaster and Lenstar in people with Cataract, run by Ziemer Ophthalmic Systems AG at 1 site in Switzerland.
Trial summary
Study question: How does the new GALILEI Lens Professional compare to predicate devices? Study hypothesis: The GALILEI Lens Professional achieves a better precision in the postoperative, calculated target refraction with cataract surgeries than predicate devices, and it is more versatile in the measurable parameters… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Galilei Lens Professional, IOLMaster and Lenstar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- spherical equivalent between -10 D and +10 D
- best-corrected VA of 20/100 or better.
Who cannot join
- strabism
- blepharitis
- nystagmus
- amblyopia
- anisometropia (spherical equivalent > 1D)
- angle closure glaucoma
Show all 12Show fewer
- seizure disorder
- brain damages
- Down syndrome
- trisomy 13 or 18
- cerebral palsy
- other serious disorders of the eye or central nervous systems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GALILEI Lens Professional vs. Predicate Devices: a Comparison Study
Study question: How does the new GALILEI Lens Professional compare to predicate devices? Study hypothesis: The GALILEI Lens Professional achieves a better precision in the postoperative, calculated target refraction with cataract surgeries than predicate devices, and it is more versatile in the measurable parameters as well as more user-friendly.
Read the detailed description
Background: An accessory to the commercially available GALILEI Dual-Scheimpflug Corneal Topographer/Keratometer with the name "EBR Accessory" was developed by the company Ziemer Ophthalmic Systems AG for the measurement of intraocular distances. The combination is called "GALILEI Lens Professional". The measurement principle is based on on short coherence interferometry/-reflectometry, which has gained wide-spread application and has been applied clinically, including one of the members of this study group, for the precise measurement of axial, intraocular distances (12.1.). Such EBR Accessory measurements, in combination with measurements by the GALILEI, may be applied to given intra-ocular lens (IOL) types and IOL equations, an permit the calculation of suggested IOLs that are implanted during cataract surgery, in order to achieve the desired vision correction. To register this accessory for sale, the precision and agreement to existing devices with similar applications ("predicate devices") must be demonstrated. One complete measurement consists of a cornea-topography/keratometry scan, followed immediately by three consecutive, axial biometry scans of the anterior segment (cornea and crystalline lens) and - after a short re-alignment - three consecutive, axial biometry scans of the retina. The measurement process is continuous, but divided in two steps. Blinking by the patient is possible in between the two steps, which increases patient comfort and, in certain cases, measurement success. Precision is evaluated by three repeated, complete measurements with the GALILEI Lens Professional and each predicate device. Two standard devices with comparable optical technology that are used in routine cataract surgery were declared as predicate devices. These two devise are typically used in combination with standard keratometers, as which the GALILEI Lens Professional may be employed as well.
Goal: The comparison of the GALILEI Lens Professional to predicate devices with respect to precision in measuring postoperative, calculated target refractions in cataract patients, and versatility of measurable quantities.
- Conditions
- Cataract
- Being tested
- Galilei Lens Professional, IOLMaster, Lenstar
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galilei Lens ProfessionalDevice
Measurement device
IOLMasterDevice
Measurement device
LenstarDevice
Measurement device
| Study group | Role | What they receive |
|---|---|---|
| Normal | Experimental | Arm: Normal eyes Interventions: Galilei Lens Professional, IOLMaster, Lenstar Receives: Device: Galilei Lens Professional; Device: IOLMaster; Device: Lenstar |
| Mild Cataract | Active comparator | Arm: Eyes with mild cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar Receives: Device: Galilei Lens Professional; Device: IOLMaster; Device: Lenstar |
| Severe cataract | Experimental | Arm: Eyes with severe cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar Receives: Device: Galilei Lens Professional; Device: IOLMaster; Device: Lenstar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement With Predicate Devices in Terms of Agreement 1
Assessed parameters:
Axial Length (AL; G6, IOLM, LS) Central Corneal Thickness (CCT; G6, LS)) Anterior Chamber Depth (ACD; G6, IOLM, LS) Lens Thickness (LT; G6, LS) Corneal Curvature (SimK; G6, IOLM, LS) White-to-White (WtW; G6, IOL, LS)
Measured: 3 months
Agreement With Predicate Devices in Terms of Agreement 2
Assessed Parameters:
Simulated Corneal Curvature (SimK; G6, IOLM, LS)
Measured: 3 months
Secondary outcomes (1)
Agreement With Devices of the Same Type in Terms of Repeatability
Assessed parameters:
Axial Length (AL) Central Corneal Thickness (CCT) Anterior Chamber Depth (ACD) Lens Thickness (LT) Corneal Curvature (SimK) White-to-White (WtW)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziemer Ophthalmic Systems AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bojan Pajic, MD, Principal investigator, Eye Clinic Orasis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961089
- Sponsor's protocol ID
- ZIOS-13/01
- Status last verified
- Sep 2019
- First submitted
- 7 Oct 2013
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GALILEI Lens Professional vs. Predicate Devices: a Comparison Study
- ClinicalTrials.gov ID
- NCT01961089
- Acronym / sponsor ID
- ZIOS-13/01
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ziemer Ophthalmic Systems AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Posted 5 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study question: How does the new GALILEI Lens Professional compare to predicate devices? Study hypothesis: The GALILEI Lens Professional achieves a better precision in the postoperative, calculated target refraction with cataract surgeries than predicate devices, and it is more versatile in the measurable parameters as well as more user-friendly.
Detailed description
Background: An accessory to the commercially available GALILEI Dual-Scheimpflug Corneal Topographer/Keratometer with the name "EBR Accessory" was developed by the company Ziemer Ophthalmic Systems AG for the measurement of intraocular distances. The combination is called "GALILEI Lens Professional". The measurement principle is based on on short coherence interferometry/-reflectometry, which has gained wide-spread application and has been applied clinically, including one of the members of this study group, for the precise measurement of axial, intraocular distances (12.1.). Such EBR Accessory measurements, in combination with measurements by the GALILEI, may be applied to given intra-ocular lens (IOL) types and IOL equations, an permit the calculation of suggested IOLs that are implanted during cataract surgery, in order to achieve the desired vision correction. To register this accessory for sale, the precision and agreement to existing devices with similar applications ("predicate devices") must be demonstrated. One complete measurement consists of a cornea-topography/keratometry scan, followed immediately by three consecutive, axial biometry scans of the anterior segment (cornea and crystalline lens) and - after a short re-alignment - three consecutive, axial biometry scans of the retina. The measurement process is continuous, but divided in two steps. Blinking by the patient is possible in between the two steps, which increases patient comfort and, in certain cases, measurement success. Precision is evaluated by three repeated, complete measurements with the GALILEI Lens Professional and each predicate device. Two standard devices with comparable optical technology that are used in routine cataract surgery were declared as predicate devices. These two devise are typically used in combination with standard keratometers, as which the GALILEI Lens Professional may be employed as well.
Goal: The comparison of the GALILEI Lens Professional to predicate devices with respect to precision in measuring postoperative, calculated target refractions in cataract patients, and versatility of measurable quantities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | Experimental | Device: Galilei Lens Professional, Device: IOLMaster, Device: LenstarArm: Normal eyes Interventions: Galilei Lens Professional, IOLMaster, Lenstar |
| Mild Cataract | Active comparator | Device: Galilei Lens Professional, Device: IOLMaster, Device: LenstarArm: Eyes with mild cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar |
| Severe cataract | Experimental | Device: Galilei Lens Professional, Device: IOLMaster, Device: LenstarArm: Eyes with severe cataract Interventions: Galilei Lens Professional, IOLMaster, Lenstar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- spherical equivalent between -10 D and +10 D
- best-corrected VA of 20/100 or better.
Key exclusion criteria (12 listed)
- strabism
- blepharitis
- nystagmus
- amblyopia
- anisometropia (spherical equivalent > 1D)
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 |
|---|---|---|
| Galilei Lens ProfessionalMeasurement device | Device | Mild Cataract, Normal, Severe cataract |
| IOLMasterMeasurement device | Device | Mild Cataract, Normal, Severe cataract |
| LenstarMeasurement device | Device | Mild Cataract, Normal, Severe cataract |
Primary outcome
Agreement With Predicate Devices in Terms of Agreement 1
Time frame: 3 months
Assessed parameters: Axial Length (AL; G6, IOLM, LS) Central Corneal Thickness (CCT; G6, LS)) Anterior Chamber Depth (ACD; G6, IOLM, LS) Lens Thickness (LT; G6, LS) Corneal Curvature (SimK; G6, IOLM, LS) White-to-White (WtW; G6, IOL, LS)
Agreement With Predicate Devices in Terms of Agreement 2
Time frame: 3 months
Assessed Parameters: Simulated Corneal Curvature (SimK; G6, IOLM, LS)
1 secondary outcome
Agreement With Devices of the Same Type in Terms of Repeatability
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bojan Pajic, MD principal investigator
Eye Clinic Orasis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galilei Lens Professional, IOLMaster and Lenstar in people with Cataract, run by Ziemer Ophthalmic Systems AG at 1 site in Switzerland.
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 12 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 8 Oct 2019. 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Agreement With Predicate Devices in Terms of Agreement 1 (time frame: 3 months). The study lists 2 primary outcomes in all. 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 8 Oct 2019.