CataractVIMECTNCT05414773
Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography®
A study testing measurement of axial length and keratometry by sonographers with a topographic module in people with Cataract, run by Edouard KOCH.
Trial summary
In order to determine the intraocular lens to be implanted during cataract surgery, keratometry and axial length must be measured in preoperative. The axial length is obtained by ocular ultrasound mode B. Keratometry is obtained by means of an automatic refractometer or corneal topography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- measurement of axial length and keratometry by sonographers with a topographic module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women Requiring CHV Cataract Surgery
- Aged 18 or over
- Insured under a social security scheme
- Having been informed of the clinical study and having given oral express consent
Who cannot join
- Person unable to express consent
- Patient with a history of corneal dystrophy, corneal refractive surgery or keratoconus.
- History of chronic corneal disease
About this study
In order to determine the intraocular lens to be implanted during cataract surgery, keratometry and axial length must be measured in preoperative. The axial length is obtained by ocular ultrasound mode B. Keratometry is obtained by means of an automatic refractometer or corneal topography. Currently, ultrasound scanners are being developed with a topography module to combine axial length and keratometry measurement. The investigators want to evaluate the corneal topography module of the Zeiss® IOL Master 700 biometer.
- Conditions
- Cataract
- Being tested
- measurement of axial length and keratometry by sonographers with a topographic module
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of axial length and keratometry by sonographers with a topographic moduleOther
measurement of axial length and keratometry by sonographers with a topographic module
| Study group | Role | What they receive |
|---|---|---|
| Corneal Topography with IOLMaster and Sirius topography. | Experimental | The experimental group will have the two exams: the topography with the IOLMAster and the topography with Sirius topography. Receives: Other: measurement of axial length and keratometry by sonographers with a topographic module |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratometry measurements
to show that the keratometry measurements obtained using the topography module integrated in the IOL Master 700 are consistent with those obtained by a standard topography in patients operated for cataract surgery. The measures will be: K1 (steepest corneal meridian), K2 (flattest corneal meridian), Kmax (central corneal keratometry), the unit of measurement is the diopter.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Jan 2024 (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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edouard KOCH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edouard KOCH, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414773
- Sponsor's protocol ID
- P21/19
- Acronym
- VIMECT
- Status last verified
- Aug 2022
- First submitted
- 3 Jun 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography®
- ClinicalTrials.gov ID
- NCT05414773
- Acronym / sponsor ID
- VIMECT / P21/19
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Edouard KOCHUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 10 Jun 2022 (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.
In order to determine the intraocular lens to be implanted during cataract surgery, keratometry and axial length must be measured in preoperative. The axial length is obtained by ocular ultrasound mode B. Keratometry is obtained by means of an automatic refractometer or corneal topography. Currently, ultrasound scanners are being developed with a topography module to combine axial length and keratometry measurement. The investigators want to evaluate the corneal topography module of the Zeiss® IOL Master 700 biometer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal Topography with IOLMaster and Sirius topography. | Experimental | Other: measurement of axial length and keratometry by sonographers with a topographic moduleThe experimental group will have the two exams: the topography with the IOLMAster and the topography with Sirius topography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and Women Requiring CHV Cataract Surgery
- Aged 18 or over
- Insured under a social security scheme
- Having been informed of the clinical study and having given oral express consent
Key exclusion criteria (3 listed)
- Person unable to express consent
- Patient with a history of corneal dystrophy, corneal refractive surgery or keratoconus.
- History of chronic corneal disease
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 |
|---|---|---|
| measurement of axial length and keratometry by sonographers with a topographic modulemeasurement of axial length and keratometry by sonographers with a topographic module | Other | Corneal Topography with IOLMaster and Sirius topography. |
Primary outcome
keratometry measurements
Time frame: day 1
to show that the keratometry measurements obtained using the topography module integrated in the IOL Master 700 are consistent with those obtained by a standard topography in patients operated for cataract surgery. The measures will be: K1 (steepest corneal meridian), K2 (flattest corneal meridian), Kmax (central corneal keratometry), the unit of measurement is the diopter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of axial length and keratometry by sonographers with a topographic module in people with Cataract, run by Edouard KOCH.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
keratometry measurements (time frame: day 1). 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 24 Aug 2022.