Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Clinical Outcomes on Trifocal IOLs FineVision POD F GF and FineVision POD F in Asian Eyes (PHY1706)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03306355
Recruitment Status : Active, not recruiting
First Posted : October 11, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Physiol

Brief Summary:
Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs with different material (hydrophobic and hydrophilic) from the same manufacturer. Implantation of the IOLs is bilaterally.

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

Detailed Description:

This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision POD F (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD F GF and POD F) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The main difference between the lenses is the material (hydrophobic and hydrophilic). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 12 study visits (1 preoperative, 2 operative and 9 postoperative) over a period of 36 months. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 3 months follow up visit and secondary endpoint data will be collected at the 3, 12, 24 and 36 months follow up visits. Data analyses will be done after the last patient finished the final examination to support the study publication plan.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Compare Clinical Outcomes of IOLs FineVision POD F GF (Hydrophobic) and FineVision POD F (Hydrophilic) After Bilateral Implantation in Asian Eyes
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : January 24, 2019
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: IOL implantation experimental
hydrophobic, trifocal intraocular lens POD F GF
Device: IOL implantation experimental
Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Active Comparator: IOL implantation active comparator
hydrophilic, trifocal intraocular lens POD F
Device: IOL implantation active comparator
Implantation of trifocal IOL POD F consisting of hydrophilic material




Primary Outcome Measures :
  1. Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. [ Time Frame: 3 months postoperative ]
    No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014


Secondary Outcome Measures :
  1. Manifested refraction [ Time Frame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)

  2. Uncorrected Distance Visual Acuity (UDVA) - monocular [ Time Frame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly.

  3. Uncorrected Distance Visual Acuity (UDVA) - binocular [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly.

  4. Corrected Distance Visual Acuity (CDVA) - monocular [ Time Frame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly.

  5. Corrected Distance Visual Acuity (CDVA) - binocular [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done binocularly.

  6. Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular [ Time Frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly.

  7. Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly.

  8. Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular [ Time Frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly.

  9. Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly.

  10. Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular [ Time Frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly.

  11. Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly.

  12. Uncorrected Near Visual Acuity at 35cm (UNVA) [ Time Frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly.

  13. Uncorrected Near Visual Acuity at 35cm (UNVA) [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly.

  14. Contrast Sensitivity [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    Contrast Sensitivity under photopic and mesopic light conditions

  15. Aberrometry [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.

  16. AcuTarget diagnostic device [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.

  17. Visual Functioning Questionnaire - 25 (VFQ-25) [ Time Frame: 3 months postoperative, 12 months postoperative. ]
    Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified Visual Functioning Questionnaire - 25 (VFQ-25) will be used. The maximum score for each questionaire is 100.

  18. Defocus Curve [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 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 -5.0 D to +1.5 D. This examination is performed monocularly and binocularly.

  19. Slitlamp examination - Corneal Status [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • Corneal Status


  20. Slitlamp examination - Fundus [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • Fundus


  21. Slitlamp examination - Signs of inflammation [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • Signs of inflammation


  22. Slitlamp examination - Pupillary block [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • Pupillary block


  23. Slitlamp examination - Retinal detachment [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • Retinal detachment


  24. Slitlamp examination - Status of anterior and posterior capsule [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • Status of anterior and posterior capsule


  25. Slitlamp examination - IOL decentration [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • IOL decentration


  26. Slitlamp examination - IOL tilt [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • IOL tilt


  27. Slitlamp examination - IOL discoloration [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • IOL discoloration


  28. Slitlamp examination - IOL opacity [ Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]

    The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

    With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

    • IOL opacity



Other Outcome Measures:
  1. Intraocular pressure (IOP) measurement [ Time Frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative. ]
    The IOP will be measured with non-contact tonometer as part of the routine follow up examinations

  2. Keratometry [ Time Frame: Pre-OP ]
    Keratometric measurements are performed to calculate the required IOL power

  3. Biometry [ Time Frame: Pre-OP ]
    Biometry measurements are performed to calculate the required IOL power



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cataractous eyes with no comorbidity
  • Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

Exclusion Criteria:

  • Unrealistic expectation
  • Age of patient <45 years
  • Irregular astigmatism
  • Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°
  • Difficulty for cooperation (distance from their home, general health condition)
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
  • Any ocular comorbidity
  • History of ocular trauma or prior ocular surgery including refractive procedures
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
  • Age-related Macular Degeneration (AMD) suspicious eyes (determined by OCT)
  • Complicated surgery

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): NCT03306355


Locations
Layout table for location information
Philippines
Asian Eye Institute
Makati City, Philippines, 1200
Sponsors and Collaborators
Physiol
Investigators
Layout table for investigator information
Principal Investigator: Robert Edward Ang, MD Asian Eye Institute

Layout table for additonal information
Responsible Party: Physiol
ClinicalTrials.gov Identifier: NCT03306355     History of Changes
Other Study ID Numbers: PHY 1706
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Physiol:
Intraocular Lens
trifocal
hydrophobic
hydrophilic

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