CataractNCT04875247
IOLMASTER 700 Central Topography Workflow Study.
An observational study of Cataract, run by OFTALVIST (Oftalmología Vistahermosa S.L) at 1 site in Spain.
Trial summary
The use of ocular biometers like IOLMaster 700, is a common practice to identify several ocular parameters such as the keratometry of the cornea and the axial length of the eye, which are necessary for calculating the power of the intraocular lens in cataract surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- IOLMaster 700 with central topography, IOLMaster 700 without central topography plus Cassini and IOLMaster 700 without central topography plus Pentacam
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 12 May 2021to 9 Sep 2021
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 50 years with cataracts that have to undergo a cataracts surgery.
Who may be able to join
- Patients that have to undergo a cataract surgery
- Patients older than 50 years.
Who cannot join
- Patients that have already undergone a previous corneal surgery.
- Patients suffering from keratoconus.
- Patients exhibiting corneal scars
- Patients exhibiting pterygium
Trial locations and contacts
1 site in 1 country.
Spain1 site
OFTALVIST (Oftalmología Vistahermosa S.L.)
Jeréz de La Frontera, Cádiz, 11407
About this study
The use of ocular biometers like IOLMaster 700, is a common practice to identify several ocular parameters such as the keratometry of the cornea and the axial length of the eye, which are necessary for calculating the power of the intraocular lens in cataract surgery. However, the additional use of other devices, such as Cassini and Pentacam is used to obtain more information of the central topography of the eye. Recently, a new version of the IOLMaster 700 equipment that provides much more detailed information than in its previous version has been presented. The objective of this study is to measure the time that the new IOLMaster 700 takes to perform these measurements of the central topography and compare it with the time it takes using the central topography using the standard IOLMaster 700 version with Cassini on one hand and Pentacam on the other.
It is hypothesized that the use of the new version of the IOLMaster 700 equipment alone can reduce the time of measurements and improve the clinic workflow.
- Conditions
- Cataract
- Being tested
- IOLMaster 700 with central topography, IOLMaster 700 without central topography plus Cassini, IOLMaster 700 without central topography plus Pentacam
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOLMaster 700 with central topographyDevice
The time needed to perform the measurement using the IOLMaster700 equipment with central topography will be recorded.
IOLMaster 700 without central topography plus CassiniDevice
The time needed to perform the measurement using the IOLMaster700 equipment without central topography plus the Cassini equipment will be recorded.
IOLMaster 700 without central topography plus PentacamDevice
The time needed to perform the measurement using the IOLMaster700 equipment without central topography plus the Pentacam equipment will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | All patients will be assigned to this cohort. Receives: Device: IOLMaster 700 with central topography; Device: IOLMaster 700 without central topography plus Cassini; Device: IOLMaster 700 without central topography plus Pentacam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time needed to do the measurements with each equipment
Time needed to do the measurements with each equipment
Measured: 1 day (Cataract pre-surgery visit)
Secondary outcomes (1)
Central topography
Measurement of keratometry (K): Flat Keratometry (K1) and Steep Keratometry (K2)
Measured: 1 day (Cataract pre-surgery visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start12 May 2021
- Primary completion9 Sep 2021
- Study completion9 Sep 2021
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramón Ruiz Mesa., Doctor, Principal investigator, OFTALVIST (Oftalmología Vistahermosa S.L)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875247
- Sponsor's protocol ID
- IOLWORK
- Status last verified
- Feb 2023
- First submitted
- 3 May 2021
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruiz-Mesa R, Ruiz-Santos M, Blanch-Ruiz J, Jimenez-Nieto A. Acquisition Time for Swept-Source Optical Biometry Plus Corneal Power Measurement During Cataract Evaluation. Clin Ophthalmol. 2022 Mar 5;16:661-668. doi: 10.2147/OPTH.S351845. eCollection 2022.
PubMed 35282169
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IOLMASTER 700 Central Topography Workflow Study.
- ClinicalTrials.gov ID
- NCT04875247
- Acronym / sponsor ID
- IOLWORK
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)Industry (pharma, biotech, devices)
- Study start
- 12 May 2021 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 6 May 2021 (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 use of ocular biometers like IOLMaster 700, is a common practice to identify several ocular parameters such as the keratometry of the cornea and the axial length of the eye, which are necessary for calculating the power of the intraocular lens in cataract surgery. However, the additional use of other devices, such as Cassini and Pentacam is used to obtain more information of the central topography of the eye. Recently, a new version of the IOLMaster 700 equipment that provides much more detailed information than in its previous version has been presented. The objective of this study is to measure the time that the new IOLMaster 700 takes to perform these measurements of the central topography and compare it with the time it takes using the central topography using the standard IOLMaster 700 version with Cassini on one hand and Pentacam on the other.
It is hypothesized that the use of the new version of the IOLMaster 700 equipment alone can reduce the time of measurements and improve the clinic workflow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Device: IOLMaster 700 with central topography, Device: IOLMaster 700 without central topography plus Cassini, Device: IOLMaster 700 without central topography plus PentacamAll patients will be assigned to this cohort. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 50 years with cataracts that have to undergo a cataracts surgery.
Key inclusion criteria (2 listed)
- Patients that have to undergo a cataract surgery
- Patients older than 50 years.
Key exclusion criteria (4 listed)
- Patients that have already undergone a previous corneal surgery.
- Patients suffering from keratoconus.
- Patients exhibiting corneal scars
- Patients exhibiting pterygium
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 |
|---|---|---|
| IOLMaster 700 with central topographyThe time needed to perform the measurement using the IOLMaster700 equipment with central topography will be recorded. | Device | Single arm |
| IOLMaster 700 without central topography plus CassiniThe time needed to perform the measurement using the IOLMaster700 equipment without central topography plus the Cassini equipment will be recorded. | Device | Single arm |
| IOLMaster 700 without central topography plus PentacamThe time needed to perform the measurement using the IOLMaster700 equipment without central topography plus the Pentacam equipment will be recorded. | Device | Single arm |
Primary outcome
Time needed to do the measurements with each equipment
Time frame: 1 day (Cataract pre-surgery visit)
Time needed to do the measurements with each equipment
1 secondary outcome
Central topography
Time frame: 1 day (Cataract pre-surgery visit)
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 17 Feb 2023.
- Results publication: PubMed 35282169Ruiz-Mesa R, Ruiz-Santos M, Blanch-Ruiz J, Jimenez-Nieto A. Acquisition Time for Swept-Source Optical Biometry Plus Corneal Power Measurement During Cataract Evaluation. Clin Ophthalmol. 2022 Mar 5;16:661-668. doi: 10.2147/OPTH.S351845. eCollection 2022.
Related trials for Cataract
RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Ramón Ruiz Mesa., Doctor principal investigator
OFTALVIST (Oftalmología Vistahermosa S.L)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by OFTALVIST (Oftalmología Vistahermosa S.L) at 1 site in Spain.
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 4 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 17 Feb 2023. 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 Spain. 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?
Time needed to do the measurements with each equipment (time frame: 1 day (Cataract pre-surgery visit)). 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 NCT04875247, 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 17 Feb 2023.