CataractNCT03396003
A Comparison of Two Devices for Taking Measurements of the Eye to Assist in Lens Selection for Cataract Surgery
A study testing GALILEI G6 Lens Professional and Oculus Pentacam AXL in people with Cataract, run by Ziemer Ophthalmic Systems AG at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the Ziemer Ophthalmic Systems AG GALILEI G6 Lens Professional to the Oculus Pentacam® AXL for taking images and measurements of the anterior segment of the eye, including the cornea, pupil, anterior chamber and lens, to assist in determining the power of the intraocular lens for… 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 G6 Lens Professional and Oculus Pentacam AXL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jan 2018to 1 Aug 2018
- 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
- Satisfies one of the subject group categories and the enrollment quota for that category has not been reached:
- Normal eyes (phakic eyes without cataracts or corneal disease, refraction ≥ -5.5 D or ≤ +5.0 D)
- Eyes having undergone previous refractive surgery (LASIK or PRK)
- Eyes with cataracts (LOCS III grading with grades 2-6 in any or all of the posterior subcapsular (P2-P5), nuclear (N2-N5) and cortical (C2-C5), assessed by slit lamp examination; no other known ocular pathology)
- Eyes with severe myopia (≤ -6 D according to the American Academy of Ophthalmology)
- Eyes with severe hyperopia (≥ +5.25 D according to the American Academy of Ophthalmology)
Show all 9Show fewer
- Eyes with previous cross-linking and eyes with advanced keratoconus
- Manifest refraction sSpherical eEquivalent Refraction (MRSER) between -10dpt and +10dpt as measured by cycloplegic autorefraction assessed less than 12 months prior to enrollment
- Best corrected visual acuity (BCVA) of LogMAR 0.2 or better
Who cannot join
- Strabismus, nystagmus, amblyopia, anisometropia (difference in MRSER>3D)
- Angle closure glaucoma
- Seizure disorder, brain damage, Down Syndrome, Trisomy 13 or 18, Cerebral Palsy or other serious ophthalmic or central nervous system disorders
- Severe dry eye
- Severe corneal scarring
- Inability to hold gaze
- Inability to see fixation target
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GALILEI G6 Lens Professional vs. a Predicate Device: a Comparison Study
The purpose of this study is to compare the Ziemer Ophthalmic Systems AG GALILEI G6 Lens Professional to the Oculus Pentacam® AXL for taking images and measurements of the anterior segment of the eye, including the cornea, pupil, anterior chamber and lens, to assist in determining the power of the intraocular lens for implantation.
Read the detailed description
A corneal topographer/biometer named GALILEI G6 Lens Professional was developed by Ziemer Ophthalmic Systems AG for the measurement of anterior segment geometry and axial intraocular distances. The measurement principle of the corneal topographer corresponds to that of the commercially available Galilei G4 Dual Scheimpflug Analyzer, whereas the measurement principle of the biometer is based on low coherence interferometry/reflectometry, which has been widely used and applied clinically by a number of predicate devices.
One complete measurement consists of a corneal topography/ tomography scan followed by three consecutive, axial biometry scans of the anterior segment (cornea and crystalline lens) and three consecutive, axial biometry scans of the retina. The measurement process is continuous but divided into three alignment-click-steps.
Such measurements can be applied to given Intra Ocular Lens (IOL) types and IOL equations, to permit the calculation of recommended IOLs to be implanted during cataract surgery in order to achieve the desired vision correction.
The primary objectives of this clinical study are to: 1) evaluate the inter-device repeatability, inter-operator repeatability and reproducibility of the GALILEI G6 Lens Professional in repeated measurements of anterior segment geometry and axial intraocular distances and, 2) demonstrate substantial equivalence through examining agreement of the GALILEI measurements to those of the predicate device, the Pentacam® AXL.
- Conditions
- Cataract
- Being tested
- GALILEI G6 Lens Professional, Oculus Pentacam AXL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GALILEI G6 Lens ProfessionalDevice
Eight measurements of the eye using the GALILEI G6 Lens Professional will be taken using two different devices and 2 different operators
Oculus Pentacam AXLDevice
A single measurement of the eye will be taken using the Oculus Pentacam AXL
| Study group | Role | What they receive |
|---|---|---|
| GALILEI G6 Lens Professional | Experimental | The GALILEI G6 Lens Professional will measure anterior segment geometry and axial intra-ocular distances of the eye. Receives: Device: GALILEI G6 Lens Professional |
| Oculus Pentacam AXL | Active comparator | The Oculus Pentacam AXL will measure anterior segment geometry and axial intra-ocular distances of the eye. Receives: Device: Oculus Pentacam AXL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length (AL) Measurement in millimeters (mm)
Repeatability and reproducability across and between evaluations
Measured: One day
Central Corneal Thickness (CCT) Measurement in micrometers (µm)
Repeatability and reproducability across and between evaluations
Measured: One day
Radius Flat Meridian (R flat) Measurement in millimeters (mm)
Repeatability and reproducability across and between evaluations
Measured: One day
Radius Steep Meridian (R steep) Measurement in millimeters (mm)
Repeatability and reproducability across and between evaluations
Measured: One day
Mean Radius (Rm) Measurement in millimeters (mm)
Repeatability and reproducability across and between evaluations
Measured: One day
Corneal Cylinder Measurement in diopters (D)
Repeatability and reproducability across and between evaluations
Measured: One day
Corneal Cylinder Axis (A flat) Measurement in degrees
Repeatability and reproducability across and between evaluations
Measured: One day
Anterior Chamber Depth (ACD) Measurement in millimeters (mm)
Repeatability and reproducability across and between evaluations
Measured: One day
Horizontal White-to-White distance (WtW) Measurement in millimeters (mm).
Repeatability and reproducability across and between evaluations
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start5 Jan 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziemer Ophthalmic Systems AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Majid Moshirfar, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396003
- Sponsor's protocol ID
- ZIEMER_G6
- Status last verified
- Sep 2018
- First submitted
- 20 Nov 2017
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GALILEI G6 Lens Professional vs. a Predicate Device: a Comparison Study
- ClinicalTrials.gov ID
- NCT03396003
- Acronym / sponsor ID
- ZIEMER_G6
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ziemer Ophthalmic Systems AGIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 10 Jan 2018 (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 purpose of this study is to compare the Ziemer Ophthalmic Systems AG GALILEI G6 Lens Professional to the Oculus Pentacam® AXL for taking images and measurements of the anterior segment of the eye, including the cornea, pupil, anterior chamber and lens, to assist in determining the power of the intraocular lens for implantation.
Detailed description
A corneal topographer/biometer named GALILEI G6 Lens Professional was developed by Ziemer Ophthalmic Systems AG for the measurement of anterior segment geometry and axial intraocular distances. The measurement principle of the corneal topographer corresponds to that of the commercially available Galilei G4 Dual Scheimpflug Analyzer, whereas the measurement principle of the biometer is based on low coherence interferometry/reflectometry, which has been widely used and applied clinically by a number of predicate devices.
One complete measurement consists of a corneal topography/ tomography scan followed by three consecutive, axial biometry scans of the anterior segment (cornea and crystalline lens) and three consecutive, axial biometry scans of the retina. The measurement process is continuous but divided into three alignment-click-steps.
Such measurements can be applied to given Intra Ocular Lens (IOL) types and IOL equations, to permit the calculation of recommended IOLs to be implanted during cataract surgery in order to achieve the desired vision correction.
The primary objectives of this clinical study are to: 1) evaluate the inter-device repeatability, inter-operator repeatability and reproducibility of the GALILEI G6 Lens Professional in repeated measurements of anterior segment geometry and axial intraocular distances and, 2) demonstrate substantial equivalence through examining agreement of the GALILEI measurements to those of the predicate device, the Pentacam® AXL.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GALILEI G6 Lens Professional | Experimental | Device: GALILEI G6 Lens ProfessionalThe GALILEI G6 Lens Professional will measure anterior segment geometry and axial intra-ocular distances of the eye. |
| Oculus Pentacam AXL | Active comparator | Device: Oculus Pentacam AXLThe Oculus Pentacam AXL will measure anterior segment geometry and axial intra-ocular distances of the eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Satisfies one of the subject group categories and the enrollment quota for that category has not been reached:
- Manifest refraction sSpherical eEquivalent Refraction (MRSER) between -10dpt and +10dpt as measured by cycloplegic autorefraction assessed less than 12 months prior to enrollment
- Best corrected visual acuity (BCVA) of LogMAR 0.2 or better
Key exclusion criteria (7 listed)
- Strabismus, nystagmus, amblyopia, anisometropia (difference in MRSER>3D)
- Angle closure glaucoma
- Seizure disorder, brain damage, Down Syndrome, Trisomy 13 or 18, Cerebral Palsy or other serious ophthalmic or central nervous system disorders
- Severe dry eye
- Severe corneal scarring
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 G6 Lens ProfessionalEight measurements of the eye using the GALILEI G6 Lens Professional will be taken using two different devices and 2 different operators | Device | GALILEI G6 Lens Professional |
| Oculus Pentacam AXLA single measurement of the eye will be taken using the Oculus Pentacam AXL | Device | Oculus Pentacam AXL |
Primary outcome
Axial Length (AL) Measurement in millimeters (mm)
Time frame: One day
Repeatability and reproducability across and between evaluations
Central Corneal Thickness (CCT) Measurement in micrometers (µm)
Time frame: One day
Repeatability and reproducability across and between evaluations
Radius Flat Meridian (R flat) Measurement in millimeters (mm)
Time frame: One day
Repeatability and reproducability across and between evaluations
Radius Steep Meridian (R steep) Measurement in millimeters (mm)
Time frame: One day
Repeatability and reproducability across and between evaluations
Mean Radius (Rm) Measurement in millimeters (mm)
Time frame: One day
Repeatability and reproducability across and between evaluations
Corneal Cylinder Measurement in diopters (D)
Time frame: One day
Repeatability and reproducability across and between evaluations
Corneal Cylinder Axis (A flat) Measurement in degrees
Time frame: One day
Repeatability and reproducability across and between evaluations
Anterior Chamber Depth (ACD) Measurement in millimeters (mm)
Time frame: One day
Repeatability and reproducability across and between evaluations
Horizontal White-to-White distance (WtW) Measurement in millimeters (mm).
Time frame: One day
Repeatability and reproducability across and between evaluations
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 26 Sep 2018.
- 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.
Majid Moshirfar, MD principal investigator
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 G6 Lens Professional and Oculus Pentacam AXL 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 9 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: finished, as of the sponsor's last update on 26 Sep 2018. 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?
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?
Axial Length (AL) Measurement in millimeters (mm) (time frame: One day). The study lists 9 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 26 Sep 2018.