A Comparison of FineVision Intraocular Lenses vs Symfony Intraocular Lenses
Primary Purpose
Cataract, Lens Opacities, Presbyopia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IOL implantation experimental
IOL implantation active comparator
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, trifocal, extended range of vision, diffractive achromatic technology
Eligibility Criteria
Inclusion Criteria:
- Cataract patients requesting independence from spectacles
- Potential visual acuity of 0.0 logMar
Exclusion Criteria:
- 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
Sites / Locations
- Department of Ophtalmology, Alexandria Main University Hospital (AMUH)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IOL implantation experimental
IOL implantation active comparator
Arm Description
Implantation of the PhysIOL FineVision POD F® IOL
Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Contrast Sensitivity
Contrast Sensitivity under photopic light conditions using the CSV-1000 contrast test.
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.
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.
Full Information
NCT ID
NCT03974451
First Posted
April 11, 2019
Last Updated
July 19, 2022
Sponsor
Beaver-Visitec International, Inc.
Collaborators
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT03974451
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 2, 2019 (Actual)
Study Completion Date
September 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beaver-Visitec International, Inc.
Collaborators
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Opacities, Presbyopia
Keywords
Intraocular Lens, trifocal, extended range of vision, diffractive achromatic technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IOL implantation experimental
Arm Type
Experimental
Arm Description
Implantation of the PhysIOL FineVision POD F® IOL
Arm Title
IOL implantation active comparator
Arm Type
Active Comparator
Arm Description
Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL.
Intervention Type
Device
Intervention Name(s)
IOL implantation experimental
Intervention Description
Implantation of of PhysIOL trifocal FineVision® POD F IOL
Intervention Type
Device
Intervention Name(s)
IOL implantation active comparator
Intervention Description
Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL
Primary Outcome Measure Information:
Title
Corrected Distance Visual Acuity at 6m (CDVA) - monocular
Description
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.
Time Frame
3 months postoperative
Secondary Outcome Measure Information:
Title
Uncorrected Distance Visual Acuity at 6m (UDVA) - monocular
Description
UDVA is measured with ETDRS charts placed in 6m distance according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.
Time Frame
3 months postoperative
Title
Uncorrected Intermediate Visual Acuity at 65cm (UIVA) - monocular
Description
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.
Time Frame
3 months postoperative
Title
Distance Corrected Intermediate Visual Acuity at 65cm (DCIVA) - monocular
Description
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.
Time Frame
3 months postoperative
Title
Uncorrected Near Visual Acuity at 35cm (UNVA)
Description
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.
Time Frame
3 months postoperative
Title
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
Description
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.
Time Frame
3 months postoperative
Title
Defocus Curve
Description
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.
Time Frame
3 months postoperative
Title
Contrast Sensitivity
Description
Contrast Sensitivity under photopic light conditions using the CSV-1000 contrast test.
Time Frame
3 months postoperative
Title
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)
Description
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.
Time Frame
3 months postoperative
Title
Manifest Refraction
Description
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.
Time Frame
3 months postoperative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cataract patients requesting independence from spectacles
Potential visual acuity of 0.0 logMar
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed H. F. Ghoneem, MD
Organizational Affiliation
Department of Ophthalmology, Faculty of Medicine, University of Alexandria,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophtalmology, Alexandria Main University Hospital (AMUH)
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison of FineVision Intraocular Lenses vs Symfony Intraocular Lenses
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