CataractNCT05055076
PMCF Retrospective Study Outcomes of a Monofocal Toric Intraocular Lens
An observational study of Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in France.
Trial summary
This is a monocentric retrospective, open-label clinical study in patients after unilateral or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC and executed only with standard of care examinations. The investigational device is CE approved. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cataract, Lens Opacities, Astigmatism
- What is being tested?
- PODEYE TORIC
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2021to 14 Dec 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who have undergone cataract surgery with mono- or bilateral implantation of POD EYE TORIC IOL (POD T 49P) and who meet all the inclusion and exclusion criteria will be invited to participate in the study. Patients will be contacted consecutively and will be enrolled after the patient informed leaflet has been given to them and after obtaining their consent to the scientific use of their data collected retrospectively (preoperative, surgery, postoperative routine visits). Patients will only be enrolled after the routine 4-6 months visit has been performed.
Who may be able to join
- Male or female adults aged 35 years or older on the day of treatment that were mono- or bilaterally implanted with PODEYE TORIC intraocular lens
- Capable of understanding the patient informed leaflet;
- Complete data available at the screening visit, surgical visit and at least one postoperative visit.
Who cannot join
- Age of patient <35 years at the day of surgery;
- Subjects who underwent previous intraocular or corneal surgery other than IO L implantation;
- Subjects in whom in-the-bag implantation was not possible;
- Subjects in whom surgical complications occurred (e.g. posterior rupture);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study to Investigate Rotational Stability and Clinical Outcomes After Implantation of a Monofocal Toric Intraocular Lens (IOL)
This is a monocentric retrospective, open-label clinical study in patients after unilateral or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC and executed only with standard of care examinations.
The investigational device is CE approved. The investigational device and all study products, including the devices used for the study examinations, have been used within the intended use specifications from the manufacturer. In addition, there were no invasive or other burdening examinations.
Read more
The investigator is an accredited and experienced cataract surgeon and researcher.
The primary endpoint is to determine rotational stability in a minimum of 120 eyes of patients with PODEYE TORIC IOL implantation after cataract surgery. Patients will be enrolled for the documentation and evaluation of retrospective data up to 6 months postoperatively.
Read the detailed description
Age-related changes of the proteins in the crystalline lens lead to cataract formation. Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.
On patients with a low amount of pre-existing corneal astigmatism (defect in the sphericity of the cornea with a focal point depending on the meridian), the implantation of a spherical monofocal IOL is the state- of- the-art when targeting a good correction of distance visual function. However, in case of pre-existing corneal astigmatism, the implantation of spherical IOLs might not be the best solution, as such lenses only correct for spherical errors and leave the astigmatism uncorrected.
Toric IOLs are obtained by adding a cylinder power to the basis optic of a given spherical power, thus correcting for both spherical and cylindrical refractive errors. Toric IOLs provide the opportunity to reduce or eliminate astigmatism, thus offering patients with pre-existing astigmatism the possibility of restoring their distance vision with reduced or no need for the use of spectacles or contact lenses with a cylindrical correction. Not correcting the astigmatism component at the time of cataract surgery is an important cause for not obtaining planned emmetropia following IOL implantation. A previous study found that more than 22% of patients undergoing cataract surgery have substantial corneal astigmatism superior than 1.25 D and would benefit from toric IOL implantation 1).
This study will add to the knowledge on toric IOLs and help improve the care of patients and the outcomes of cataract surgery after toric IOL implantation.
The study is a monocentric, retrospective study to investigate rotational stability and visual performance after mono- or bilateral implantation of PODEYE TORIC intraocular lens following cataract surgery, executed only with standard of care examinations. The study outcomes will be used to confirm the safety performance for a stable IOL positioning of the investigation al device.
Preoperative, surgical and postoperative data (up to 6 months after surgery) will be collected retrospectively by reviewing the patient charts.
The investigational device PODEYE TORIC IOL is CE approved and commercially available in the country where this clinical investigation is being carried out. The investigational device and all study products, including the devices used for the study examinations, have been used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
- Conditions
- Cataract, Lens Opacities, Astigmatism
- Being tested
- PODEYE TORIC
- 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.
PODEYE TORICDevice
Patients will be contacted consecutively and will be enrolled after the patient informed leaflet has been given to them and after obtaining their consent to the scientific use of their data collected retrospectively (preoperative, surgery, postoperative routine visits). Patients will only be enrolled after the routine 4-6 months visit has been performed.
| Study group | Role | What they receive |
|---|---|---|
| PODEYE TORIC | Adult patients who have undergone cataract surgery with mono- or bilateral implantation of POD EYE TORIC IOL (POD T 49P) and who meet all the inclusion and exclusion criteria will be invited to participate in the study. Receives: Device: PODEYE TORIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational Stability
Rotational stability is an important parameter on toric IOLs, as postoperative IO L rotation can lead to inappropriate correction of corneal astig matism and decrease in uncorrected distance visual acuity.
The primary study endpoint is the absolute value of rotation between the day of surgery and the postoperative visit 6 months after surgery. The absolute value of rotation should be less than 10° in 90% of the eyes implanted with POD EYE TORIC lens according to safety declarations of EN ISO 11979-7:2018.
Measured: 6 months
Secondary outcomes (1)
Stability of Manifest Refraction (Spherical Equivalent)
Manifest refraction will be assessed using the spherical equivalent: Manifest refraction Spherical
Equivalent (MRSE). Negative cylinder notation will be used. MRSE is calculated by the following formula:
MRSE = sphere + 1/2 cylinder. Descriptive analysis of sphere, cylinder and MRS E will be reported. Stability of the MRSE will be assessed by summarizing the change in MRSE between adjacent visits ( mean, standard deviation, minimum and maximum, and 95% confidence interval).
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 posted23 Sep 2021
- Study start1 Aug 2021
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055076
- Sponsor's protocol ID
- PHY2120
- Status last verified
- Aug 2022
- First submitted
- 14 Sep 2021
- Last updated
- 23 Aug 2022
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Investigate Rotational Stability and Clinical Outcomes After Implantation of a Monofocal Toric Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT05055076
- Acronym / sponsor ID
- PHY2120
- Conditions
- Cataract, Lens Opacities, Astigmatism
- Keywords
- Intraocular Lens, Monofocal, Toric Lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 23 Sep 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 monocentric retrospective, open-label clinical study in patients after unilateral or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC and executed only with standard of care examinations.
The investigational device is CE approved. The investigational device and all study products, including the devices used for the study examinations, have been used within the intended use specifications from the manufacturer. In addition, there were no invasive or other burdening examinations.
The investigator is an accredited and experienced cataract surgeon and researcher.
The primary endpoint is to determine rotational stability in a minimum of 120 eyes of patients with PODEYE TORIC IOL implantation after cataract surgery. Patients will be enrolled for the documentation and evaluation of retrospective data up to 6 months postoperatively.
Detailed description
Age-related changes of the proteins in the crystalline lens lead to cataract formation. Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.
On patients with a low amount of pre-existing corneal astigmatism (defect in the sphericity of the cornea with a focal point depending on the meridian), the implantation of a spherical monofocal IOL is the state- of- the-art when targeting a good correction of distance visual function. However, in case of pre-existing corneal astigmatism, the implantation of spherical IOLs might not be the best solution, as such lenses only correct for spherical errors and leave the astigmatism uncorrected.
Toric IOLs are obtained by adding a cylinder power to the basis optic of a given spherical power, thus correcting for both spherical and cylindrical refractive errors. Toric IOLs provide the opportunity to reduce or eliminate astigmatism, thus offering patients with pre-existing astigmatism the possibility of restoring their distance vision with reduced or no need for the use of spectacles or contact lenses with a cylindrical correction. Not correcting the astigmatism component at the time of cataract surgery is an important cause for not obtaining planned emmetropia following IOL implantation. A previous study found that more than 22% of patients undergoing cataract surgery have substantial corneal astigmatism superior than 1.25 D and would benefit from toric IOL implantation 1).
This study will add to the knowledge on toric IOLs and help improve the care of patients and the outcomes of cataract surgery after toric IOL implantation.
The study is a monocentric, retrospective study to investigate rotational stability and visual performance after mono- or bilateral implantation of PODEYE TORIC intraocular lens following cataract surgery, executed only with standard of care examinations. The study outcomes will be used to confirm the safety performance for a stable IOL positioning of the investigation al device.
Preoperative, surgical and postoperative data (up to 6 months after surgery) will be collected retrospectively by reviewing the patient charts.
The investigational device PODEYE TORIC IOL is CE approved and commercially available in the country where this clinical investigation is being carried out. The investigational device and all study products, including the devices used for the study examinations, have been used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PODEYE TORIC | – | Device: PODEYE TORICAdult patients who have undergone cataract surgery with mono- or bilateral implantation of POD EYE TORIC IOL (POD T 49P) and who meet all the inclusion and exclusion criteria will be invited to participate in the study. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have undergone cataract surgery with mono- or bilateral implantation of POD EYE TORIC IOL (POD T 49P) and who meet all the inclusion and exclusion criteria will be invited to participate in the study. Patients will be contacted consecutively and will be enrolled after the patient informed leaflet has been given to them and after obtaining their consent to the scientific use of their data collected retrospectively (preoperative, surgery, postoperative routine visits). Patients will only be enrolled after the routine 4-6 months visit has been performed.
Key inclusion criteria (3 listed)
- Male or female adults aged 35 years or older on the day of treatment that were mono- or bilaterally implanted with PODEYE TORIC intraocular lens
- Capable of understanding the patient informed leaflet;
- Complete data available at the screening visit, surgical visit and at least one postoperative visit.
Key exclusion criteria (4 listed)
- Age of patient <35 years at the day of surgery;
- Subjects who underwent previous intraocular or corneal surgery other than IO L implantation;
- Subjects in whom in-the-bag implantation was not possible;
- Subjects in whom surgical complications occurred (e.g. posterior rupture);
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 |
|---|---|---|
| PODEYE TORICPatients will be contacted consecutively and will be enrolled after the patient informed leaflet has been given to them and after obtaining their consent to the scientific use of their data collected retrospectively (preoperative, surgery, postoperative routine visits). Patients will only be enrolled after the routine 4-6 months visit has been performed. | Device | PODEYE TORIC |
Primary outcome
Rotational Stability
Time frame: 6 months
Rotational stability is an important parameter on toric IOLs, as postoperative IO L rotation can lead to inappropriate correction of corneal astig matism and decrease in uncorrected distance visual acuity. The primary study endpoint is the absolute value of rotation between the day of surgery and the postoperative visit 6 months after surgery. The absolute value of rotation should be less than 10° in 90% of the eyes implanted with POD EYE TORIC lens according to safety declarations of EN ISO 11979-7:2018.
1 secondary outcome
Stability of Manifest Refraction (Spherical Equivalent)
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 23 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in France.
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 3 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 23 Aug 2022. 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 France. 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 (time frame: 6 months). 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 23 Aug 2022.