CataractNCT04944238
A-constant Optimization of a Toric Monofocal IOL
An observational study of Cataract, run by Beaver-Visitec International, Inc. at 1 site in Belgium.
Trial summary
The study is a prospective series study to determine the IOL constant of a hydrophilic toric monofocal intra-ocular lens (IOL) Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Ankoris
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Nov 2014to 11 Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pseudophakic patients implanted with one of the two IOLs
Who may be able to join
- Patient older than 50 years old
- Age-related cataract
- Corneal astigmatisme >1 D
- Age 21 and older
- Visual Acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
Who cannot join
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
- Previous ocular surgery or trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens
The study is a prospective series study to determine the IOL constant of a hydrophilic toric monofocal intra-ocular lens (IOL)
Read the detailed description
The study is a prospective series study with he principal objective to determine the IOL constant.
The secondary objectives of this study are to determine the rotational stability of the Ankoris intraocular lens and to measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
Although there may be no direct benefit to the subjects under study, the investigation will determined the optimized constant for accurate IOL power calculation and will assess the stability and efficacy of the toric optics: this would result in a benefit for the patient population. Since the material, the overall design of the IOL as well as the measuring procedure in this study is well tolerated in standard clinical practice and the IOL is readily available and CE-marked, the benefit/risk ratio appears acceptable.
- Conditions
- Cataract
- Being tested
- Ankoris
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnkorisDevice
Implantations of test lens using standard phaco surgical technique, with aim for in-the-bag implantation.
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with Ankoris IOL | To assess the IOL stability, slitlamp photos of the consecutive 30 patients with respect to time will then be analysed with a 5% confidence interval. Receives: Device: Ankoris |
What is being measured
The primary outcome is the main question the study is designed to answer.
The principal objective of the study is to determine the IOL constant.
IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.
Measured: 1-2 hours
The principal objective of the study is to determine the IOL constant.
IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.
Measured: 1 month
The principal objective of the study is to determine the IOL constant.
IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.
Measured: 3 months
Secondary outcomes (3)
Rotational stability
To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
Measured: 1-2 hours
Rotational stability
To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
Measured: 1 month
Rotational stability
To measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
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 posted29 Jun 2021
- Study start3 Nov 2014
- Primary completion19 Mar 2018
- Study completion11 Jun 2019
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Sallet, MD, Principal investigator, Private Eye Institue Aalst, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944238
- Sponsor's protocol ID
- PHY2014
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens
- ClinicalTrials.gov ID
- NCT04944238
- Acronym / sponsor ID
- PHY2014
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 29 Jun 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 study is a prospective series study to determine the IOL constant of a hydrophilic toric monofocal intra-ocular lens (IOL)
Detailed description
The study is a prospective series study with he principal objective to determine the IOL constant.
The secondary objectives of this study are to determine the rotational stability of the Ankoris intraocular lens and to measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.
Although there may be no direct benefit to the subjects under study, the investigation will determined the optimized constant for accurate IOL power calculation and will assess the stability and efficacy of the toric optics: this would result in a benefit for the patient population. Since the material, the overall design of the IOL as well as the measuring procedure in this study is well tolerated in standard clinical practice and the IOL is readily available and CE-marked, the benefit/risk ratio appears acceptable.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with Ankoris IOL | – | Device: AnkorisTo assess the IOL stability, slitlamp photos of the consecutive 30 patients with respect to time will then be analysed with a 5% confidence interval. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pseudophakic patients implanted with one of the two IOLs
Key inclusion criteria (6 listed)
- Patient older than 50 years old
- Age-related cataract
- Corneal astigmatisme >1 D
- Age 21 and older
- Visual Acuity > 0.05
Key exclusion criteria (2 listed)
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
- Previous ocular surgery or trauma.
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 |
|---|---|---|
| AnkorisImplantations of test lens using standard phaco surgical technique, with aim for in-the-bag implantation. | Device | Patients implanted with Ankoris IOL |
Primary outcome
The principal objective of the study is to determine the IOL constant.
Time frame: 1-2 hours
IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.
The principal objective of the study is to determine the IOL constant.
Time frame: 1 month
IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.
The principal objective of the study is to determine the IOL constant.
Time frame: 3 months
IOL constant optimisation for PCI axial length measurement of Physiol Ankoris IOL.
3 secondary outcomes
Rotational stability
Time frame: 1-2 hours
Rotational stability
Time frame: 1 month
Rotational stability
Time frame: 3 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 29 Jun 2021.
- 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.
Guy Sallet, MD principal investigator
Private Eye Institue Aalst, Belgium
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 Beaver-Visitec International, Inc. at 1 site in Belgium.
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 6 inclusion and 2 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 29 Jun 2021. 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 Belgium. 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?
The principal objective of the study is to determine the IOL constant. (time frame: 1-2 hours). The study lists 3 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 29 Jun 2021.