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CataractNCT03688399

Comparison of Clinical Outcomes POD L GF vs POD F GF (PHY1707)

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

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

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract, Lens Opacity, Presbyopia
What is being tested?
IOL implantation experimental and IOL implantation comparator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteHungary
Study dates
30 Jul 2018to 21 Sep 2021
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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Cataractous eyes and/or patients suffering from presbyopia with no ocular comorbidity
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

Who cannot join

  • Age of patient <40 years
  • Irregular astigmatism
  • Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°
  • Difficulty for cooperation (distance from their home, general health condition)
  • 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
Show all 11Show fewer
  • 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, chronic Uveitis, Marfan's syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
  • AMD suspicious eyes
  • Complicated surgery

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Semmelweis University - Department of Ophthalmology

    Budapest, 1085

Other trials in Hungary

About this study

Official title: Clinical Study to Compare Clinical Outcomes of Hydrophobic Trifocal IOLs FineVision POD F GF and FineVision POD L GF After Bilateral Implantation

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.

Read the detailed description

This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.

Primary and secondary endpoint data will be collected at the 6 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Being tested
IOL implantation experimental, IOL implantation comparator
Keywords
Intraocular Lens, trifocal, cataract, PhysIOL
Medical subject headings
Cataract, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IOL implantation experimentalDevice

    Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near

  • IOL implantation comparatorDevice

    Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate

Study groups in NCT03688399
Study groupRoleWhat they receive
IOL Implantation experimentalExperimentalhydrophobic, trifocal intraocular lens POD L GF with light distribution far > intermediate > near
Receives: Device: IOL implantation experimental
IOL Implantation ComparatorActive comparatorhydrophobic, trifocal intraocular lens POD F GF with light distribution far > near > intermediate
Receives: Device: IOL implantation comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.

    No statistically significant difference between the two study groups on monocular CDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014.

    Measured: 3 months postoperative

Secondary outcomes (18)

  1. Manifested refraction

    The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)

    Measured: 3 months postoperative

  2. Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.

    Measured: 3 months postoperative

  3. Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions

    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.

    Measured: 6 months postoperative

  4. Corrected Distance Visual Acuity (CDVA) under photopic light conditions

    CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done binocularly under photopic light conditions.

    Measured: 3 months postoperative

  5. Corrected Distance Visual Acuity (CDVA) under mesopic light conditions

    CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.

    Measured: 6 months postoperative

  6. Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under photopic light conditions

    DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.

    Measured: 3 months postoperative

  7. Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under mesopic light conditions

    DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.

    Measured: 6 months postoperative

  8. Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under photopic light conditions

    UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.

    Measured: 3 months postoperative

  9. Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under mesopic light conditions

    UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.

    Measured: 6 months postoperative

  10. Distance Corrected Near Visual Acuity at 35cm (DCNVA) under photopic light conditions

    DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.

    Measured: 3 months postoperative

  11. Distance Corrected Near Visual Acuity at 35cm (DCNVA) under mesopic light conditions

    DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.

    Measured: 6 months postoperative

  12. Uncorrected Near Visual Acuity at 35cm (UNVA) under photopic light conditions

    UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.

    Measured: 3 months postoperative

  13. Uncorrected Near Visual Acuity at 35cm (UNVA) under mesopic light conditions

    UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.

    Measured: 6 months postoperative

  14. Contrast Sensitivity (monocular)

    Contrast Sensitivity under photopic and mesopic light conditions

    Measured: 6 months postoperative

  15. Contrast Sensitivity (binocular)

    Contrast Sensitivity under photopic and mesopic light conditions

    Measured: 3 months postoperative

  16. Questionnaire: Visual Functioning Questionnaire - 25 (VFQ-25, National Eye Institute)

    Patient reported outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified questionnaire VFQ-25 (National Eye Institute) will be used. This questionnaire consists of 25 questions. Each answer is scaled between a score of 0 and 100 according to a predefined calculation algorithm, with 100 always being the best possible outcome.

    Additionally subscales are calculated as an average value of several answers belonging to the same set of questions.

    The subscales are:

    • General Health
    • General Vision
    • Ocular Pain
    • Near Activities
    • Distance Activities
    • Social Functioning
    • Mental Health
    • Role Difficulties
    • Dependancy
    • Driving
    • Color Vision
    • Peripheral Vision

    Measured: 3 months postoperative

  17. Defocus Curve monocular

    To assess the visual acuity for different distances, defocus curves under photopic and mesopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. This examination is performed monocularly.

    Measured: 1 month postoperative

  18. Defocus Curve binocular

    To assess the visual acuity for different distances, defocus curves under photopic and mesopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. This examination is performed binocularly.

    Measured: 3 months postoperative

Timeline

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

  1. First posted28 Sep 2018
  2. Study start30 Jul 2018
  3. Primary completion1 Feb 2021
  4. Study completion21 Sep 2021

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03688399
Sponsor's protocol ID
PHY1707
Status last verified
Jan 2022
First submitted
26 Sep 2018
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

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

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 11 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 11 Jan 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 Hungary. 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?

Monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions. (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?

On the ClinicalTrials.gov record for NCT03688399.

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 11 Jan 2022.

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