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出境医 / 临床实验 / A Comparison of FineVision Intraocular Lenses vs Symfony Intraocular Lenses

A Comparison of FineVision Intraocular Lenses vs Symfony Intraocular Lenses

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.

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 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
Actual Primary Completion Date : June 2, 2019
Actual Study Completion Date : September 2, 2019
Arms and Interventions
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

Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
Egypt
Department of Ophtalmology, Alexandria Main University Hospital (AMUH)
Alexandria, Egypt
Sponsors and Collaborators
Beaver-Visitec International, Inc.
Alexandria University
Investigators
Layout table for investigator information
Principal Investigator: Mohammed H. F. Ghoneem, MD Department of Ophthalmology, Faculty of Medicine, University of Alexandria,
Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE January 1, 2018
Actual Primary Completion Date June 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Contrast Sensitivity [ Time Frame: 3 months postoperative ]
    Contrast Sensitivity under photopic light conditions using the CSV-1000 contrast test.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of FineVision Intraocular Lenses vs Symfony Intraocular Lenses
Official Title  ICMJE Visual Performance After Trifocal vs Extended Range of Vision Presbyopia-correcting Intraocular Lenses
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Lens Opacities
  • Presbyopia
Intervention  ICMJE
  • Device: IOL implantation experimental
    Implantation of of PhysIOL trifocal FineVision® POD F IOL
  • Device: IOL implantation active comparator
    Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL
Study Arms  ICMJE
  • Experimental: IOL implantation experimental
    Implantation of the PhysIOL FineVision POD F® IOL
    Intervention: Device: IOL implantation experimental
  • Active Comparator: IOL implantation active comparator
    Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL.
    Intervention: Device: IOL implantation active comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2019)
16
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
20
Actual Study Completion Date  ICMJE September 2, 2019
Actual Primary Completion Date June 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974451
Other Study ID Numbers  ICMJE Finevision vs Symfony IOL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohammed Ghoneem, Beaver-Visitec International, Inc.
Study Sponsor  ICMJE Beaver-Visitec International, Inc.
Collaborators  ICMJE Alexandria University
Investigators  ICMJE
Principal Investigator: Mohammed H. F. Ghoneem, MD Department of Ophthalmology, Faculty of Medicine, University of Alexandria,
PRS Account Beaver-Visitec International, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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