Clinical trial NCT03974451: A Comparison of FineVision Intraocular Lenses vs Symfony Intraocular Lenses
Official title: Visual Performance After Trifocal vs Extended Range of Vision Presbyopia-correcting Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Presbyopia
Keywords: Intraocular Lens
trifocal
extended range of vision
diffractive achromatic technology
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Alexandria University
First posted: 2019-06-05
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Cataract patients requesting independence from spectacles
2. Potential visual acuity of 0.0 logMar

Exclusion Criteria:

1. Unrealistic expectations (sharp clear vision is the main concern of the patient)
2. Ocular pathology besides cataract (glaucoma, macular degeneration, retinopathies, corneal opacities, corneal guttata.. etc.)
3. Previous refractive surgery
4. Expected pathology after surgery (p.e. uveitis, diabetic retinopathy, PEX)
5. Preoperative corneal astigmatism of \> 1.0 D
6. Any intraocular or postoperative complication
7. Dry eye disease
8. History of ocular trauma

Primary outcomes:
measure: Corrected Distance Visual Acuity at 6m (CDVA) - monocular
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Uncorrected Distance Visual Acuity at 6m (UDVA) - monocular
timeFrame: 3 months postoperative
measure: Uncorrected Intermediate Visual Acuity at 65cm (UIVA) - monocular
timeFrame: 3 months postoperative
measure: Distance Corrected Intermediate Visual Acuity at 65cm (DCIVA) - monocular
timeFrame: 3 months postoperative
measure: Uncorrected Near Visual Acuity at 35cm (UNVA)
timeFrame: 3 months postoperative
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
timeFrame: 3 months postoperative
measure: Defocus Curve
timeFrame: 3 months postoperative
measure: Contrast Sensitivity
timeFrame: 3 months postoperative
measure: National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)
timeFrame: 3 months postoperative
measure: Manifest Refraction
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Department of Ophtalmology, Alexandria Main University Hospital (AMUH)
Study officials:
affiliation: Department of Ophthalmology, Faculty of Medicine, University of Alexandria,
name: Mohammed H. F. Ghoneem, MD
role: PRINCIPAL_INVESTIGATOR
References: