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Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery

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ClinicalTrials.gov Identifier: NCT04054427
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Physiol

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE August 13, 2019
Last Update Posted Date September 27, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
Monocular Best Corrected Distance Visual Acuity (CDVA) [ Time Frame: 6 months (120-180 days) postoperative ]
Statistically significant non-inferiority with POD L GF on monocular CDVA in comparison to literature data. A significance level of 0.05 will be considered statistically significant.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04054427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2019)
  • Manifest refraction (sphere and cylinder) [ Time Frame: Pre-OP, 1-2 days post operative, 30-60 days postoperative, 120-180 days 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
  • Pupil Size Photopic [ Time Frame: 120-180 days postoperative ]
    Photopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).
  • Pupil Size Mesopic [ Time Frame: 120-180 days postoperative ]
    Mesopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the mesopic pupil diameters, eye illumination should be identical to that used for mesopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).
  • Uncorrected Distance Visual Acuity (UDVA) - monocular [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]
    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
  • Uncorrected Distance Visual Acuity (UDVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Corrected Distance Visual Acuity (CDVA) - monocular [ Time Frame: Pre-OP, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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 under photopic conditions.
  • Corrected Distance Visual Acuity (CDVA) - binocular [ Time Frame: 120-180 days postoperative ]
    Monocular and Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic and mesopic light conditions at 80cm distance
  • Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
  • Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular mesopic [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
  • Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
  • Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular mesopic. [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
  • Uncorrected Near Visual Acuity at 40cm (UNVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
  • Uncorrected Near Visual Acuity at 40cm (UNVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
  • Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
  • Distance Corrected Near Visual Acuity at 40cm (DCNVA) - binocular [ Time Frame: 120-180 days postoperative ]
    DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
  • Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular mesopic [ Time Frame: 120-180 days postoperative ]
    DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
  • Defocus Curve [ Time Frame: 120-180 days 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 +2.0 D. This examination is performed binocularly
  • Binocular Contrast Sensitivity under photopic light conditions [ Time Frame: 120-180 days postoperative ]
    Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.
  • Binocular Contrast Sensitivity under mesopic light conditions [ Time Frame: 120-180 days postoperative ]
    Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.
  • Binocular Contrast Sensitivity under mesopic light conditions and using a glare source [ Time Frame: 120-180 days postoperative ]
    Contrast Sensitivity under mesopic light conditions with a glare source using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.
  • Patient reported outcomes: Quality of Vision Questionnaire (QoV) quality of vision [ Time Frame: 120-180 days postoperative ]
    Quality of vision based on response to each question in the Quality of Vision (QoV) questionnaire. Answer is a choice of 4 options, the first being the least and the fourth being the most based on question type, i.e. "never" to "very often" or "not at all" to "severe".
  • Patient reported outcomes: Near Activity Visual Questionnaire (NAVQ) quality of vision [ Time Frame: 120-180 days postoperative ]
    Quality of vision based on response (choice of 0-3 with 0 meaning no difficulty and 3 meaning extreme difficulty) to each question in the Near Activity Visual Questionnaire (NAVQ)
  • Slit lamp examination - Corneal Status [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Fundus examination with dilated pupil [ Time Frame: Pre Op, 120-180 days 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
  • Slit lamp examination - Signs of inflammation [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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 Anterior chamber cells, Anterior chamber flare, Cystoid macular oedema, Hypopyon, and Endophthalmitis
  • Slit lamp examination - Pupillary block [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - Retinal detachment [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - Status of anterior and posterior capsule [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - IOL decentration [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - IOL tilt [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - IOL discoloration [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - IOL opacity [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • Manifest refraction (sphere and cylinder) [ Time Frame: Pre-OP, 1-2 days post operative, 30-60 days postoperative, 120-180 days 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
  • Pupil Size Photopic [ Time Frame: 120-180 days postoperative ]
    Photopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).
  • Pupil Size Mesopic [ Time Frame: 120-180 days postoperative ]
    Mesopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the mesopic pupil diameters, eye illumination should be identical to that used for mesopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).
  • Uncorrected Distance Visual Acuity (UDVA) - monocular [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]
    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
  • Uncorrected Distance Visual Acuity (UDVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Corrected Distance Visual Acuity (CDVA) - monocular [ Time Frame: Pre-OP, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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 under photopic conditions.
  • Corrected Distance Visual Acuity (CDVA) - binocular [ Time Frame: 120-180 days postoperative ]
    Monocular and Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic and mesopic light conditions at 80cm distance
  • Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
  • Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular mesopic [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
  • Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
  • Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
  • Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular mesopic. [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
  • Uncorrected Near Visual Acuity at 40cm (UNVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
  • Uncorrected Near Visual Acuity at 40cm (UNVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
  • Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
  • Distance Corrected Near Visual Acuity at 40cm (DCNVA) - binocular [ Time Frame: 120-180 days postoperative ]
    DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
  • Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular mesopic [ Time Frame: 120-180 days postoperative ]
    DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
  • Defocus Curve [ Time Frame: 120-180 days 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 +2.0 D. This examination is performed binocularly
  • Binocular Contrast Sensitivity under photopic light conditions [ Time Frame: 120-180 days postoperative ]
    Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.
  • Binocular Contrast Sensitivity under mesopic light conditions [ Time Frame: 120-180 days postoperative ]
    Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.
  • Binocular Contrast Sensitivity under mesopic light conditions and using a glare source [ Time Frame: 120-180 days postoperative ]
    Contrast Sensitivity under mesopic light conditions with a glare source using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.
  • Patient reported outcomes [ Time Frame: 120-180 days postoperative ]
    Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment
  • Slit lamp examination - Corneal Status [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Fundus examination with dilated pupil [ Time Frame: Pre Op, 120-180 days 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
  • Slit lamp examination - Signs of inflammation [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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 Anterior chamber cells, Anterior chamber flare, Cystoid macular oedema, Hypopyon, and Endophthalmitis
  • Slit lamp examination - Pupillary block [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - Retinal detachment [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - Status of anterior and posterior capsule [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - IOL decentration [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - IOL tilt [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - IOL discoloration [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
  • Slit lamp examination - IOL opacity [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days 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
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2019)
  • Intraocular pressure (IOP) measurement [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]
    The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018
  • Keratometry [ Time Frame: Pre-OP ]
    Keratometric measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
  • Biometry [ Time Frame: Pre-OP ]
    Biometry measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
  • IOL power and target refraction [ Time Frame: Operative (day of Surgery) ]
    The parameter of the implanted IOL must be recorded as well as the target refraction given by the IOL calculator. This parameter is needed to calculate the accuracy of achieving the target refraction. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
  • Fundus OCT [ Time Frame: Pre-OP ]
    An OCT (optical coherence tomography) image will be taken at the preoperative visit to identify AMD suspicious eyes that need to be excluded from this study. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
Official Title  ICMJE Clinical Study to Investigate Visual Performance and Patient Satisfaction After Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
Brief Summary Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive surgery.
Detailed Description

This clinical investigation is a controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study whereby patients undergoing routine cataract surgery that previously underwent refractive surgery prior to being screened will have bilateral implantation of trifocal intraocular lens FineVision POD L GF (PhysIOL, Liège, Belgium).

The study purpose is to collect clinical data on visual acuity, contrast sensitivity and patient reported outcomes obtained on patients with cataracts and/or suffering from presbyopia that underwent refractive surgery prior to the IOL implantation.

The device under investigation (FineVision POD L GF) is a trifocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 28 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD L GF intraocular lens.

Subjects participating in the trial will attend a total of 9 study visits (1 preoperative, 2 operative and 6 postoperative) over a period of 6 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Lens Opacities
  • Presbyopia
Intervention  ICMJE Device: IOL implantation experimental
Implantation of trifocal IOL POD L GF consisting of hydrophobic material
Study Arms  ICMJE Experimental: IOL implantation experimental
hydrophobic, trifocal intraocular lens POD L GF
Intervention: Device: IOL implantation experimental
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2019)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cataracteous eyes with no comorbidity;
  • Post LASIK, post PRK/surface ablation or post RK (radial keratotomy) patients with day of refractive surgery minimum 24 months before IOL implantation;
  • Calculated IOL power is within the range of the study IOLs;
  • Fulfill CHRU (Centre Hospitalier Regional Universitaire) internal criteria for multifocal lenses implantation on post-refractive surgery patients.
  • Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia;
  • Clear intraocular media other than cataract;
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
  • Signed informed consent

Exclusion Criteria:

  • Age of patient < 45 years;
  • Irregular topographic examination where limitation in clinical outcomes are expected.
  • Patients that underwent presbyopia correcting refractive surgery (e.g. PresbyLASIK, SUPRACOR, INTRACOR)
  • Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
  • Subjects with AMD suspicious eyes as determined by OCT examination;
  • Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
  • Traumatic cataract;
  • History or presence of macular edema;
  • Concurrent or previous (within 30 days) participation in another drug or device investigation;
  • Instability of keratometry or biometry measurements;
  • Ocular hypertension or glaucoma;
  • Significant dry eye;
  • Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgement (reason to be documented on the CRF).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jochen Kandulla, PhD +49 157 862 75281 j.kandulla@physiol.be
Contact: Rebecca McQuaid, PhD +353871212615 r.mcquaid@physiol.be
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04054427
Other Study ID Numbers  ICMJE PHY1902
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 Physiol
Study Sponsor  ICMJE Physiol
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Béatrice Cochener, Prof Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis
PRS Account Physiol
Verification Date September 2019

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