CataractNCT03974451
A Comparison of FineVision Intraocular Lenses vs Symfony Intraocular Lenses
A study testing IOL implantation experimental and IOL implantation active comparator in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Egypt.
Trial summary
This is a prospective randomised open-label study with the aim to compare the visual performance of the trifocal FineVision® IOL versus the extended range of vision Symfony® IOL after phaco-emulsification cataract surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Opacities, Presbyopia
- What is being tested?
- IOL implantation experimental and IOL implantation active comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 2 Sep 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cataract patients requesting independence from spectacles
- Potential visual acuity of 0.0 logMar
Who cannot join
- Unrealistic expectations (sharp clear vision is the main concern of the patient)
- Ocular pathology besides cataract (glaucoma, macular degeneration, retinopathies, corneal opacities, corneal guttata.. etc.)
- Previous refractive surgery
- Expected pathology after surgery (p.e. uveitis, diabetic retinopathy, PEX)
- Preoperative corneal astigmatism of > 1.0 D
- Any intraocular or postoperative complication
- Dry eye disease
- History of ocular trauma
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Ophtalmology, Alexandria Main University Hospital (AMUH)
Alexandria
About this study
Official title: Visual Performance After Trifocal vs Extended Range of Vision Presbyopia-correcting Intraocular Lenses
This is a prospective randomised open-label study with the aim to compare the visual performance of the trifocal FineVision® IOL versus the extended range of vision Symfony® IOL after phaco-emulsification cataract surgery.
Read the detailed description
With the advent of a new intraocular lens (IOL) materials, technologies and advanced optics, higher spectacle independence after surgery is now possible.
Multifocal IOLs work by splitting light into different foci, which is known to generate photic effects. Trifocal optics, which have been available on the European market since 2010, offer spectacle independence in most cases. Typically, visual acuity is maintained throughout the whole range of vision from distance to near vision, and general patient satisfaction has proven that trifocal IOLs are well tolerated by patients.
Patients having irregular corneal astigmatism, large pupils and weak zonules were considered unsuitable candidates for multifocal IOLs, while patients who aim for spectacle independence and with low pre-operative regular astigmatism were considered to be good candidates.
The Fine Vision IOL (PhysIOL®; Liège, Belgium) is a diffractive trifocal IOL that provides an intermediate focus at 1.75 D and a near focus at 3.5 D (both at the IOL plane). This corresponds to a nominal intermediate add of approximately +1,15 D and near add of about 2,25 D at the corneal plane, depending on the geometry of the patient's eye. This intermediate focal point is expected to improve patient satisfaction relative to bifocal IOLs, since bifocal IOLs have a greater drop off in visual acuity (VA) in the intermediate range. There is a concern that the addition of a third focal point may increase halos, However, a relatively small percentage of energy is dedicated to intermediate vision when compared to distance and near vision. The trifocal diffractive structure asymmetrically directs incident light to distant (50%) intermediate (20%) and near (30%) focal points, independent of pupil diameter (up to 4,5 mm).
The FineVision is an aspheric trifocal IOL composed of 25% hydrophilic acrylic material with a blue light and ultraviolet light blocker. It has a total diameter of 10,75 mm and an optic body diameter of 6,15 mm.
The Tecnis Symfony is an extended range of vision IOL based on diffractive achromatic technology. The IOL has an achromatic diffractive pattern that elongates the focus and compensates for the chromatic aberration of the cornea. According to the manufacturer, halos are not expected with this IOL, because it provides an elongated focal area rather than one or various focal points. The IOL has a biconvex wavefront-designed anterior aspheric surface and a posterior achromatic diffractive surface. The total diameter of the IOL is 13.0 mm, and the optic zone diameter is 6.0 mm. It is an ultraviolet-filtering hydrophobic acrylic material with a refractive index of 1,47 at 35° C.
This is a prospective randomised open-label study with the aim to compare the visual performance of the trifocal FineVision® IOL versus the extended range of vision Symphony® IOL after phaco-emulsification cataract surgery.
All patients will undergo and complete preoperative ophthalmologic examinations including refractive status, uncorrected and corrected near and distance visual acuities, biometry and keratometry.
Postoperative, all patients will receive topical antibiotic treatment for 1 week and topical steroid tapered treatment for 4 weeks as well as NSAID topical treatment for 4 weeks. All patients will be followed up after 2 days, 1 week and 3 months.
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Being tested
- IOL implantation experimental, IOL implantation active comparator
- Keywords
- Intraocular Lens, trifocal, extended range of vision, diffractive achromatic technology
- 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 of PhysIOL trifocal FineVision® POD F IOL
IOL implantation active comparatorDevice
Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL
| Study group | Role | What they receive |
|---|---|---|
| IOL implantation experimental | Experimental | Implantation of the PhysIOL FineVision POD F® IOL Receives: Device: IOL implantation experimental |
| IOL implantation active comparator | Active comparator | Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL. Receives: Device: IOL implantation active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected Distance Visual Acuity at 6m (CDVA) - monocular
CDVA is measured with ETDRS charts placed in 6m distance with best aided corrective glasses according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.
Measured: 3 months postoperative
Secondary outcomes (9)
Uncorrected Distance Visual Acuity at 6m (UDVA) - monocular
UDVA is measured with ETDRS charts placed in 6m distance according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.
Measured: 3 months postoperative
Uncorrected Intermediate Visual Acuity at 65cm (UIVA) - monocular
UIVA is measured with ETDRS charts placed in 65cm distance. The examination is done without corrective glasses and according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.
Measured: 3 months postoperative
Distance Corrected Intermediate Visual Acuity at 65cm (DCIVA) - monocular
DCIVA is measured with ETDRS charts placed in 65cm distance with corrective glasses for far distance according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.
Measured: 3 months postoperative
Uncorrected Near Visual Acuity at 35cm (UNVA)
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.
Measured: 3 months postoperative
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.
Measured: 3 months postoperative
Defocus Curve
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -4.0 D to 0.0 D. This examination is performed monocularly.
Measured: 3 months postoperative
Contrast Sensitivity
Contrast Sensitivity under photopic light conditions using the CSV-1000 contrast test.
Measured: 3 months postoperative
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)
For this study, the validated and verified questionnaire VFQ-25 (National Eye Institute) will be used. The VFQ-25 consists of a base set of 25 vision- targeted questions representing 11 vision-related constructs (General Health, General Vision, Ocular Pain,Near Activities, Distance Activities, Vision Specific (Social Functioning, Mental Health, Role Difficulties, Dependency), Driving, Color Vision, Peripheral Vision), plus an additional single-item general health rating question.
The minimum score is 0 and the maximum score is 100 for each construct. Higher values represent a better outcome.
Measured: 3 months postoperative
Manifest Refraction
The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to International Standards Organization (ISO) 11979-7:2014.
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.
- First posted5 Jun 2019
- Study start1 Jan 2018
- Primary completion2 Jun 2019
- Study completion2 Sep 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alexandria University
- Responsible party
- Sponsor
- Investigators
- Mohammed H. F. Ghoneem, MD, Principal investigator, Department of Ophthalmology, Faculty of Medicine, University of Alexandria,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974451
- Sponsor's protocol ID
- Finevision vs Symfony IOL
- Status last verified
- Jul 2022
- First submitted
- 11 Apr 2019
- Last updated
- 22 Jul 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 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance After Trifocal vs Extended Range of Vision Presbyopia-correcting Intraocular Lenses
- ClinicalTrials.gov ID
- NCT03974451
- Acronym / sponsor ID
- Finevision vs Symfony IOL
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Keywords
- Intraocular Lens, trifocal, extended range of vision, diffractive achromatic technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alexandria University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 5 Jun 2019 (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 prospective randomised open-label study with the aim to compare the visual performance of the trifocal FineVision® IOL versus the extended range of vision Symfony® IOL after phaco-emulsification cataract surgery.
Detailed description
With the advent of a new intraocular lens (IOL) materials, technologies and advanced optics, higher spectacle independence after surgery is now possible.
Multifocal IOLs work by splitting light into different foci, which is known to generate photic effects. Trifocal optics, which have been available on the European market since 2010, offer spectacle independence in most cases. Typically, visual acuity is maintained throughout the whole range of vision from distance to near vision, and general patient satisfaction has proven that trifocal IOLs are well tolerated by patients.
Patients having irregular corneal astigmatism, large pupils and weak zonules were considered unsuitable candidates for multifocal IOLs, while patients who aim for spectacle independence and with low pre-operative regular astigmatism were considered to be good candidates.
The Fine Vision IOL (PhysIOL®; Liège, Belgium) is a diffractive trifocal IOL that provides an intermediate focus at 1.75 D and a near focus at 3.5 D (both at the IOL plane). This corresponds to a nominal intermediate add of approximately +1,15 D and near add of about 2,25 D at the corneal plane, depending on the geometry of the patient's eye. This intermediate focal point is expected to improve patient satisfaction relative to bifocal IOLs, since bifocal IOLs have a greater drop off in visual acuity (VA) in the intermediate range. There is a concern that the addition of a third focal point may increase halos, However, a relatively small percentage of energy is dedicated to intermediate vision when compared to distance and near vision. The trifocal diffractive structure asymmetrically directs incident light to distant (50%) intermediate (20%) and near (30%) focal points, independent of pupil diameter (up to 4,5 mm).
The FineVision is an aspheric trifocal IOL composed of 25% hydrophilic acrylic material with a blue light and ultraviolet light blocker. It has a total diameter of 10,75 mm and an optic body diameter of 6,15 mm.
The Tecnis Symfony is an extended range of vision IOL based on diffractive achromatic technology. The IOL has an achromatic diffractive pattern that elongates the focus and compensates for the chromatic aberration of the cornea. According to the manufacturer, halos are not expected with this IOL, because it provides an elongated focal area rather than one or various focal points. The IOL has a biconvex wavefront-designed anterior aspheric surface and a posterior achromatic diffractive surface. The total diameter of the IOL is 13.0 mm, and the optic zone diameter is 6.0 mm. It is an ultraviolet-filtering hydrophobic acrylic material with a refractive index of 1,47 at 35° C.
This is a prospective randomised open-label study with the aim to compare the visual performance of the trifocal FineVision® IOL versus the extended range of vision Symphony® IOL after phaco-emulsification cataract surgery.
All patients will undergo and complete preoperative ophthalmologic examinations including refractive status, uncorrected and corrected near and distance visual acuities, biometry and keratometry.
Postoperative, all patients will receive topical antibiotic treatment for 1 week and topical steroid tapered treatment for 4 weeks as well as NSAID topical treatment for 4 weeks. All patients will be followed up after 2 days, 1 week and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOL implantation experimental | Experimental | Device: IOL implantation experimentalImplantation of the PhysIOL FineVision POD F® IOL |
| IOL implantation active comparator | Active comparator | Device: IOL implantation active comparatorImplantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Cataract patients requesting independence from spectacles
- Potential visual acuity of 0.0 logMar
Key exclusion criteria (8 listed)
- Unrealistic expectations (sharp clear vision is the main concern of the patient)
- Ocular pathology besides cataract (glaucoma, macular degeneration, retinopathies, corneal opacities, corneal guttata.. etc.)
- Previous refractive surgery
- Expected pathology after surgery (p.e. uveitis, diabetic retinopathy, PEX)
- Preoperative corneal astigmatism of > 1.0 D
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 experimentalImplantation of of PhysIOL trifocal FineVision® POD F IOL | Device | IOL implantation experimental |
| IOL implantation active comparatorImplantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL | Device | IOL implantation active comparator |
Primary outcome
Corrected Distance Visual Acuity at 6m (CDVA) - monocular
Time frame: 3 months postoperative
CDVA is measured with ETDRS charts placed in 6m distance with best aided corrective glasses according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.
9 secondary outcomes
Uncorrected Distance Visual Acuity at 6m (UDVA) - monocular
Time frame: 3 months postoperative
Uncorrected Intermediate Visual Acuity at 65cm (UIVA) - monocular
Time frame: 3 months postoperative
Distance Corrected Intermediate Visual Acuity at 65cm (DCIVA) - monocular
Time frame: 3 months postoperative
Uncorrected Near Visual Acuity at 35cm (UNVA)
Time frame: 3 months postoperative
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
Time frame: 3 months postoperative
Defocus Curve
Time frame: 3 months postoperative
Contrast Sensitivity
Time frame: 3 months postoperative
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)
Time frame: 3 months postoperative
Manifest Refraction
Time frame: 3 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 22 Jul 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.
Mohammed H. F. Ghoneem, MD principal investigator
Department of Ophthalmology, Faculty of Medicine, University of Alexandria,
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 and IOL implantation active comparator in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Egypt.
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 2 inclusion and 8 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 22 Jul 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 Egypt. 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?
Corrected Distance Visual Acuity at 6m (CDVA) - monocular (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 22 Jul 2022.