CataractPHY2013NCT04933487
Rotational Stability Analysis of a Toric Monofocal IOL
A study testing IOL implantation experimental in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Germany.
Trial summary
This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract, Lens Opacities, Astigmatism
- What is being tested?
- IOL implantation experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 26 Aug 2014to Mar 2019
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataracteous Eyes with no comorbidity
- Regular corneal astigmatism >1 dioptre and <3D determined by an automatic keratometer (regularity determined by the topography of the keratometry).
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent •>50 years old
Who cannot join
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
- Any ocular comorbidity
- History of ocular trauma or prior ocular surgery including refractive procedures
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, Marfan's syndrome)
- Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of the Rotational Stability of the Ankoris Intraocular Lens
This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris.
Read the detailed description
This is a single-center, prospective, nonrandomized PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens (Ankoris). The device under investigation is manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism.
The primary objective of this study is to determine the rotational stability of the Ankoris intraocular lens. The secondary objective is to measure the residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.
In total approx. 20 eyes of 20 patients will be recruited for this clinical study.
Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery. Subjects would have the option for unscheduled visits if required medically.
- Conditions
- Cataract, Lens Opacities, Astigmatism
- Being tested
- IOL implantation experimental
- Keywords
- Intraocular Lens, Monofocal, Toric Lens
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL implantation experimentalDevice
Monolateral implantation of toric intraocular lenses Ankoris. (Manufactured by PhysIOL sa/nv, Liège, Belgium).
| Study group | Role | What they receive |
|---|---|---|
| Ankoris IOL Implantation experimental | Experimental | Monolateral implantation of toric intraocular lenses Ankoris Receives: Device: IOL implantation experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
Rotational stability of the ANKORIS is evaluated on the basis of slit-lamp photographies to capture the iris and the marks onto the lens. Descriptive statistics will be used to determine the IOL stability.
Measured: 3 months postoperative
Secondary outcomes (1)
Residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.
Visual performance is determined in terms of monocular uncorrected distance visual acuity (UDVA), distance corrected visual acuity (DCVA) and postoperative refraction. Efficiency will be assessed using Alpins method.
Measured: Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start26 Aug 2014
- Primary completion1 Jan 2016
- Study completionMar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Responsible party
- Sponsor
- Investigators
- Burkhard Dick, MD, Principal investigator, Ruhr-Universitat Bochum, Bochum, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933487
- Sponsor's protocol ID
- PHY2013
- Acronym
- PHY2013
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 21 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 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Rotational Stability of the Ankoris Intraocular Lens
- ClinicalTrials.gov ID
- NCT04933487
- Acronym / sponsor ID
- PHY2013 / PHY2013
- Conditions
- Cataract, Lens Opacities, Astigmatism
- Keywords
- Intraocular Lens, Monofocal, Toric Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Study start
- 26 Aug 2014 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 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.
This is a single-center, prospective PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens Ankoris.
Detailed description
This is a single-center, prospective, nonrandomized PMCF study whereby patients undergoing routine cataract surgery will have monolateral implantation of hydrophilic monofocal toric intraocular lens (Ankoris). The device under investigation is manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism.
The primary objective of this study is to determine the rotational stability of the Ankoris intraocular lens. The secondary objective is to measure the residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.
In total approx. 20 eyes of 20 patients will be recruited for this clinical study.
Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery. Subjects would have the option for unscheduled visits if required medically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankoris IOL Implantation experimental | Experimental | Device: IOL implantation experimentalMonolateral implantation of toric intraocular lenses Ankoris |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cataracteous Eyes with no comorbidity
- Regular corneal astigmatism >1 dioptre and <3D determined by an automatic keratometer (regularity determined by the topography of the keratometry).
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent •>50 years old
Key exclusion criteria (5 listed)
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
- Any ocular comorbidity
- History of ocular trauma or prior ocular surgery including refractive procedures
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, Marfan's syndrome)
- Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
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 |
|---|---|---|
| IOL implantation experimentalMonolateral implantation of toric intraocular lenses Ankoris. (Manufactured by PhysIOL sa/nv, Liège, Belgium). | Device | Ankoris IOL Implantation experimental |
Primary outcome
Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
Time frame: 3 months postoperative
Rotational stability of the ANKORIS is evaluated on the basis of slit-lamp photographies to capture the iris and the marks onto the lens. Descriptive statistics will be used to determine the IOL stability.
1 secondary outcome
Residual astigmatism after Ankoris implantation with respect to the targeted astigmatism correction.
Time frame: Follow-ups will be performed 1 day, 1 month, and 3 months after cataract surgery
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 21 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Burkhard Dick, MD principal investigator
Ruhr-Universitat Bochum, Bochum, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL implantation experimental in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Germany.
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 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 21 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 Germany. 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?
Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation (time frame: 3 months postoperative). 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 21 Jun 2021.