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A Comparison of FineVision Intraocular Lenses vs Symfony Intraocular Lenses

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ClinicalTrials.gov Identifier: NCT03974451
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Mohammed Ghoneem, Physiol

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.

Condition or disease Intervention/treatment Phase
Cataract Lens Opacities Presbyopia Device: IOL implantation experimental Device: IOL implantation active comparator Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Performance After Trifocal vs Extended Range of Vision Presbyopia-correcting Intraocular Lenses
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: IOL implantation experimental
Implantation of the PhysIOL FineVision POD F® IOL
Device: IOL implantation experimental
Implantation of of PhysIOL trifocal FineVision® POD F IOL

Active Comparator: IOL implantation active comparator
Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL.
Device: IOL implantation active comparator
Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Uncorrected Distance Visual Acuity at 6m (UDVA) - monocular [ Time Frame: 3 months postoperative ]
    UDVA is measured with ETDRS charts placed in 6m distance according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.

  2. Uncorrected Intermediate Visual Acuity at 65cm (UIVA) - monocular [ Time Frame: 3 months postoperative ]
    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.

  3. Distance Corrected Intermediate Visual Acuity at 65cm (DCIVA) - monocular [ Time Frame: 3 months postoperative ]
    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.

  4. Uncorrected Near Visual Acuity at 35cm (UNVA) [ Time Frame: 3 months postoperative ]
    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.

  5. Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular [ Time Frame: 3 months postoperative ]
    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.

  6. Defocus Curve [ Time Frame: 3 months postoperative ]
    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.

  7. Contrast Sensitivity [ Time Frame: 3 months postoperative ]
    Contrast Sensitivity under photopic light conditions using the CSV-1000 contrast test.

  8. National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) [ Time Frame: 3 months postoperative ]

    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.


  9. Manifest Refraction [ Time Frame: 3 months postoperative ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974451


Contacts
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Contact: Mohammed H. F. Ghoneem, MD +201025258850 mohammedghoneem@gmailmohammedghoneem@gmail.com

Locations
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Egypt
Department of Ophtalmology, Alexandria Main University Hospital (AMUH) Recruiting
Alexandria, Egypt
Contact: Mohammed H. F. Ghoneem, MD    +201025258850    mohammedghoneem@gmail.com   
Sponsors and Collaborators
Physiol
Alexandria University
Investigators
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Principal Investigator: Mohammed H. F. Ghoneem, MD Department of Ophthalmology, Faculty of Medicine, University of Alexandria,

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Responsible Party: Mohammed Ghoneem, Principal Investigator and MD Alexandria University, Physiol
ClinicalTrials.gov Identifier: NCT03974451     History of Changes
Other Study ID Numbers: Finevision vs Symfony IOL
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohammed Ghoneem, Physiol:
Intraocular Lens
trifocal
extended range of vision
diffractive achromatic technology

Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors