CataractPHY2101NCT04744467

PMCF Study on Monofocal Toric IOL (PODEYE TORIC)

A study testing IOL implantation experimental in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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: 12 participants
Where: 1 siteCzechia
Study dates: 5 May 2021to 19 Dec 2023
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

Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes;
Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs;
Regular corneal astigmatism (measured by a topographer);
Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes;
Capability to understand and sign an IRB approved informed consent form and privacy authorization;
Clear intraocular media other than cataract;

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Dilated pupil size large enough to visualize IOL axis markings postoperatively;
Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL implantation;
Willing and able to conform to the study requirements.

Who cannot join

Age of patient <50 years at the day of screening;
Regular corneal astigmatism <0.75 D or >4.25 D (measured by an automatic keratometer) in both eyes
Irregular astigmatism (measured by a topographer);
Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
Subjects with AMD suspicious eyes as determined by OCT examination;
Previous intraocular or corneal surgery;

Show all 21Show fewer

Traumatic cataract;
History or presence of macular edema;
Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes;
Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
Concurrent or previous (within 30 days) participation in another drug or device investigation;
Clinically significant dry eye as determined by the investigator' s judgement;
Ocular surface disease (clinical symptoms or keratitis);
Patients showing contraindications as listed in the current Instructions for use (IFU);
Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).
In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:
zonular instability;
need for iris manipulation;
capsular fibrosis or other opacity; and
inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

Gemini Eye Clinic
Zlín, 760 01

Other trials in Czechia

About this study

Official title: Post-market Clinical Follow-Up (PMCF) Study to Investigate Rotational Stability, Visual Performance, Contrast Sensitivity, Patient Satisfaction and PCO Rate After Implantation of a Monofocal Toric IOL

Read the detailed description

This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC. The device under investigation is a hydrophobic acrylic monofocal toric intraocular lens (IOL) 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.

If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be received an implantation with the monofocal parent lens PODEYE.

The study purpose is to determine safety, rotational stability, refractive and visual performance, contrast sensitivity, patient satisfaction and PCO rate after mono- or bilateral implantation of PODEYE TORIC intraocular lens.

In total approx. 15 patients will be recruited for this clinical study and undergo mono- or bilateral implantation of PODEYE TORIC intraocular lens. The maximum time between 1st and 2nd eye implantation is 30 days.

Subjects participating in the trial will attend a total of maximum 12 study visits over a period of 330-420 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 days postoperative visits). 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
Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).

Study groups in NCT04744467
Study group	Role	What they receive
PODEYE TORIC IOL Implantation experimental	Experimental	Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC 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
The primary performance endpoint is to show statistically non-inferior rotational stability outcomes on PODEYE TORIC lens compared to CER data obtained for a multifocal toric IOL (POD FT) by the same manufacturer sharing the same haptic design but based on a hydrophilic lens material. The null hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is not larger than the absolute mean IOL rotation reported in the current CER on POD FT lens.
The alternative hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is larger than the outcomes reported in the current CER on POD FT lens. The measure is taken at 6 months postoperative visit compared to the measurement performed within 10 minutes after surgery.
Measured: 6 months postoperative

Secondary outcomes (2)

Best Corrected Distance Visual Acuity compared to historical Data
The objective is to compare CDVA above defined thresholds of the investigational product to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.3 and E.4). The null hypothesis for the CDVA is that / when the true rate of cases with visual acuity 0.3 logMAR or better is less than or equal to the SPE rate. The alternative hypothesis is that the "success" rate is higher than the SPE rate. If the distance corrected visual acuity is 0.3 logMAR or better in 30 eyes or more (with 36 eyes included), the null hypothesis could be rejected, and the alternative hypothesis could be accepted.
Measured: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Change in cylindrical Power of the Eye
Change in cylindrical power, defined as the difference between magnitude of preoperative keratometric cylinder and postoperative manifest cylinder is calculated at every Form. The outcomes of this calculation will be stratified per 0.25D step of preoperative keratometric cylinder and descriptive statistics (mean, standard deviation, median, minimum, maximum) will be provided.
In addition, the following outcomes will be tabulated (stratified per 0.25D step of preoperative keratometric cylinder):
- The proportion that showed a "reduction in cylindrical power of the eye" <0.50 D
- The proportion that showed a "reduction in cylindrical power of the eye" ≥0.50 D
- The proportion that showed change in absolute value "reduction in cylindrical power of the eye" ≤ 0.50 D Also, regression analysis will be performed comparing "Reduction in cylindrical power of the eye" (corneal plane) and preoperative keratometric cylinder.
Measured: Pre-Op, 1 month postoperative, 6 months postoperative, 12 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 202119 Dec 2023

First posted9 Feb 2021
Study start5 May 2021
Primary completion8 Jun 2023
Study completion19 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04744467
Sponsor's protocol ID: PHY2101
Acronym: PHY2101
Status last verified: Aug 2024
First submitted: 29 Jan 2021
Last updated: 20 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
PubMed 20505205
Kretz FT, Breyer D, Klabe K, Hagen P, Kaymak H, Koss MJ, Gerl M, Mueller M, Gerl RH, Auffarth GU. Clinical Outcomes After Implantation of a Trifocal Toric Intraocular Lens. J Refract Surg. 2015 Aug;31(8):504-10. doi: 10.3928/1081597X-20150622-01.
PubMed 26274516

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market Clinical Follow-Up (PMCF) Study to Investigate Rotational Stability, Visual Performance, Contrast Sensitivity, Patient Satisfaction and PCO Rate After Implantation of a Monofocal Toric IOL
ClinicalTrials.gov ID: NCT04744467
Acronym / sponsor ID: PHY2101 / PHY2101
Conditions: Cataract, Lens Opacities, Astigmatism
Keywords: Intraocular Lens, Monofocal, Toric Lens
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
Collaborators: targomedGmbH
Study start: 5 May 2021 (actual)
Primary completion: 8 Jun 2023 (actual)
Study completion: 19 Dec 2023 (actual)
First posted: 9 Feb 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PODEYE TORIC IOL Implantation experimental	Experimental	Device: IOL implantation experimentalMono- or bilateral implantation of toric intraocular lenses PODEYE TORIC

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes;
Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs;
Regular corneal astigmatism (measured by a topographer);
Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes;
Capability to understand and sign an IRB approved informed consent form and privacy authorization;

Key exclusion criteria (21 listed)

Age of patient <50 years at the day of screening;
Regular corneal astigmatism <0.75 D or >4.25 D (measured by an automatic keratometer) in both eyes
Irregular astigmatism (measured by a topographer);
Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
Subjects with AMD suspicious eyes as determined by OCT examination;

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 experimentalMono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).	Device	PODEYE TORIC IOL Implantation experimental

Primary outcome

Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
Time frame: 6 months postoperative
The primary performance endpoint is to show statistically non-inferior rotational stability outcomes on PODEYE TORIC lens compared to CER data obtained for a multifocal toric IOL (POD FT) by the same manufacturer sharing the same haptic design but based on a hydrophilic lens material. The null hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is not larger than the absolute mean IOL rotation reported in the current CER on POD FT lens. The alternative hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is larger than the outcomes reported in the current CER on POD FT lens. The measure is taken at 6 months postoperative visit compared to the measurement performed within 10 minutes after surgery.

2 secondary outcomes

Best Corrected Distance Visual Acuity compared to historical Data
Time frame: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Change in cylindrical Power of the Eye
Time frame: Pre-Op, 1 month postoperative, 6 months postoperative, 12 months postoperative

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 20 Aug 2024.
Background: PubMed 20505205McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
Background: PubMed 26274516Kretz FT, Breyer D, Klabe K, Hagen P, Kaymak H, Koss MJ, Gerl M, Mueller M, Gerl RH, Auffarth GU. Clinical Outcomes After Implantation of a Trifocal Toric Intraocular Lens. J Refract Surg. 2015 Aug;31(8):504-10. doi: 10.3928/1081597X-20150622-01.
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.

Pavel Stodulka, MD principal investigator

Gemini Eye Clinic

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 Czechia.

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 9 inclusion and 21 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 20 Aug 2024. 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 Czechia. 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: 6 months postoperative). 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 NCT04744467, which also lists 2 linked publications.

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 20 Aug 2024.