Optical Biometer, CataractsBIO-CAT-DENSANCT05239715
Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract
An observational study of Optical Biometer, Cataracts, run by OFTALVIST (Oftalmología Vistahermosa S.L) at 1 site in Spain.
Trial summary
To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Optical Biometer, Cataracts
- What is being tested?
- Ocular biometry
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2022to 31 Oct 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with dense cataracts.
Who may be able to join
- LOCS III cataract classification with a grade of ≥3 for nuclear, cortical or posterior subcapsular.
- DLI index, from the ITrace device, should be ≤ 5.
Who cannot join
- Previous continuous contact lens wear
- Ocular trauma
- Intraocular lens surgery
- Poor fixation
- Corneal disease (i.e. keratoconus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract: Benefit of Use of the Enhance Retina Visualization Mode
To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts
Read the detailed description
To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts
- Conditions
- Optical Biometer, Cataracts
- Being tested
- Ocular biometry
- Keywords
- optical biometer, cataracts
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular biometryDiagnostic test
Biometry using swept-source OCT Argos, swept-source OCT IOLMaster 700, swept-source OCT Anterion, PCI Pentacam AXL, OcuScan RxP and Itrace measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe and compare the acquisition rate between different biometers in eyes To describe and compare the acquisition success rate between different biometers in eyes with advanced cataracts
Acquision succes rate is indicated by a percentage, from 0% to 100%. The biometer can obtain (success) or not (failure) the measurement. This value will be indicated for each biometer.
Measured: 6 months
Secondary outcomes (1)
To describe the correlation of success rate and Dysfunctional Lens Index (DLI, iTrace)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start10 Feb 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 Optical Biometer, CataractsStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Pedro Tañá, Dr., Principal investigator, Oftalmología Vistahermosa SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239715
- Sponsor's protocol ID
- BIO-CAT-DENSA
- Acronym
- BIO-CAT-DENSA
- Status last verified
- Sep 2023
- First submitted
- 3 Feb 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tana-Rivero P, Aguilar-Corcoles S, Tana-Sanz P, Tana-Sanz S, Montes-Mico R. Axial length acquisition success rates and agreement of four optical biometers and one ultrasound biometer in eyes with dense cataracts. Eye Vis (Lond). 2023 Sep 1;10(1):35. doi: 10.1186/s40662-023-00352-3.
PubMed 37653460
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three SS-OCT and One PCI Optical Biometers in Eyes With Dense Cataract: Benefit of Use of the Enhance Retina Visualization Mode
- ClinicalTrials.gov ID
- NCT05239715
- Acronym / sponsor ID
- BIO-CAT-DENSA / BIO-CAT-DENSA
- Conditions
- Optical Biometer, Cataracts
- Keywords
- optical biometer, cataracts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)Industry (pharma, biotech, devices)
- Collaborators
- Alcon Research
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 15 Feb 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.
To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts
Detailed description
To describe and compare the acquisition rate between different biometers in eyes with advanced cataracts
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with dense cataracts.
Key inclusion criteria (2 listed)
- LOCS III cataract classification with a grade of ≥3 for nuclear, cortical or posterior subcapsular.
- DLI index, from the ITrace device, should be ≤ 5.
Key exclusion criteria (5 listed)
- Previous continuous contact lens wear
- Ocular trauma
- Intraocular lens surgery
- Poor fixation
- Corneal disease (i.e. keratoconus)
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 |
|---|---|---|
| Ocular biometryBiometry using swept-source OCT Argos, swept-source OCT IOLMaster 700, swept-source OCT Anterion, PCI Pentacam AXL, OcuScan RxP and Itrace measurement | Diagnostic test | – |
Primary outcome
To describe and compare the acquisition rate between different biometers in eyes To describe and compare the acquisition success rate between different biometers in eyes with advanced cataracts
Time frame: 6 months
Acquision succes rate is indicated by a percentage, from 0% to 100%. The biometer can obtain (success) or not (failure) the measurement. This value will be indicated for each biometer.
1 secondary outcome
To describe the correlation of success rate and Dysfunctional Lens Index (DLI, iTrace)
Time frame: 6 months
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 6 Sep 2023.
- Results publication: PubMed 37653460Tana-Rivero P, Aguilar-Corcoles S, Tana-Sanz P, Tana-Sanz S, Montes-Mico R. Axial length acquisition success rates and agreement of four optical biometers and one ultrasound biometer in eyes with dense cataracts. Eye Vis (Lond). 2023 Sep 1;10(1):35. doi: 10.1186/s40662-023-00352-3.
- Individual participant dataSharing planned: No
Related trials for Optical Biometer, Cataracts
Recruiting
Development of Optical Biometer
Cataract and IOL Surgery
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.
Pedro Tañá, Dr. principal investigator
Oftalmología Vistahermosa SL
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 Optical Biometer, Cataracts, 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 5 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 6 Sep 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?
To describe and compare the acquisition rate between different biometers in eyes To describe and compare the acquisition success rate between different biometers in eyes with advanced cataracts (time frame: 6 months). 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 NCT05239715, 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 6 Sep 2023.