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Completed

NCT Number: NCT03306355

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Lens Opacities Presbyopia Refractive Errors

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Eye Institute

Makati City, 1200, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IOL implantation experimental

Device

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

IOL implantation active comparator

Device

Implantation of trifocal IOL POD F consisting of hydrophilic material

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Registry information

Official study 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

Acronym: PHY1706

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
Oct 11, 2017
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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