Clinical Study to Investigate Outcomes of Trifocal Toric IOL POD FT in Asian Eyes
- Conditions
- CataractPresbyopiaLens Opacities
- Interventions
- Device: IOL implantation experimental
- Registration Number
- NCT03844828
- Lead Sponsor
- Beaver-Visitec International, Inc.
- Brief Summary
Prospective, controlled, single-surgeon, single-center clinical study to compare visual acuity outcomes to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425)
- Detailed Description
This is a prospective, controlled, single-surgeon, single-center clinical study, whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of trifocal toric intraocular lenses POD FT. The study is aimed to compare visual acuity outcomes the FineVision POD FT IOL to data obtained in a similar study by the same principal investigator on the trifocal FineVision POD F IOL (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425), whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the FineVision POD FT IOL in both eyes or, in case the corneal astigmatism in one of the two eyes of the same patient is too small to implant a toric lens, the FineVision POD F IOL will be implanted in this eye (both lenses: PhysIOL, Liège, Belgium).
The devices under investigation (FineVision POD FT 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 that that the POD FT IOL is the toric version of the POD F IOL. 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 11 study visits (1 preoperative, 2 operative and 8 postoperative) over a period of 24 months. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the 6 months follow up visit and secondary endpoint data will be collected at the 1 Day, 1 Week, 1 month, 6, 12 and 24 months postoperative visits. Data analyses will be done after the last patient finished the final examination to support the study publication plan
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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;
- Regular corneal astigmatism ≥0.75 dioptres (measured by an automatic keratometer or biometer) in one or both eyes;
- Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- Clear intraocular media other than cataract;
- Calculated IOL power is within the range of the study IOLs;
- Dilated pupil size large enough to visualize IOL axis markings postoperatively;
- Willing and able to conform to the study requirements.
- Regular corneal astigmatism <0.75 dioptres (measured by an automatic keratometer or biometer) in both eyes
- Irregular astigmatism;
- 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;
- Previous intraocular or corneal surgery;
- Traumatic cataract;
- History or presence of macular edema;
- Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
- 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 judgment (reason to be documented on eCRF).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description POD FT IOL Implantation experimental IOL implantation experimental Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT and POD F.
- Primary Outcome Measures
Name Time Method Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions. 6 months (120-180 days) postoperative Monocular visual acuity outcomes on CDVA under photopic light conditions are statistically non-inferior to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F (study no. PHY1802, ClinicalTrials.gov ID: NCT03688425).
- Secondary Outcome Measures
Name Time Method Uncorrected Distance Visual Acuity (UDVA) - binocular 6 months postoperative, 12 months postoperative, 24 months 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.
Uncorrected Near Visual Acuity at 35cm (UNVA) - monocular 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions
Uncorrected Near Visual Acuity at 35cm (UNVA) - binocular 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions
Manifested refraction Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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)
Corrected Distance Visual Acuity (CDVA) - monocular Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions.
Corrected Distance Visual Acuity (CDVA) - binocular 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions.
Pupil Size 6 months postoperative Photopic and mesopic 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. 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).
The examination is performed and documented according to the guidelines in ISO 11979-7:2018.Uncorrected Distance Visual Acuity (UDVA) - monocular Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months 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 Intermediate Visual Acuity at 70cm (UIVA) - monocular 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions.
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular mesopic 6 months postoperative, 12 months postoperative, 24 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 under mesopic conditions
Defocus Curve 6 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 binocularly.
Binocular Contrast Sensitivity under photopic light conditions 6 months postoperative, 12 months postoperative, 24 months postoperative Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Slitlamp examination - Pupillary block Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 blockSlitlamp examination - Status of anterior and posterior capsule Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 capsuleUncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions.
Slitlamp examination - Corneal Status Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 StatusDistance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular 6 months postoperative, 12 months postoperative, 24 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 under photopic conditions.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular mesopic. 6 months postoperative, 12 months postoperative, 24 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 under mesopic conditions.
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source 6 months postoperative, 12 months postoperative, 24 months 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.
Photograph of IOL with dilated pupil to asses IOL rotation OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative This examination shall only be performed in eyes implanted with POD FT lenses. To determine the rotational stability of the toric lenses after implantation, the actual IOL orientation has to be recorded as the intended surgical position during surgery using a photograph through the surgery microscope or other technique in order to document the rotational position of the IOL. Additional orientations are measured and recorded at the follow up visits by taking retroilluminated photographs in mydriasis using the slit lamp.
To determine the rotational stability it is important that the IOL axis marks of the toric IOL are visible as well concurrent structures of the eye (in the same image) that are fixed and stable. Preferred fixed structures are limbal vessels. The pupil is dilated if necessary to visualize the IOL axis marks.Slitlamp examination - IOL decentration Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 decentrationBinocular Contrast Sensitivity under mesopic light conditions 6 months postoperative, 12 months postoperative, 24 months postoperative Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Patient reported outcomes 6 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 questionnaire Quality of Vision (QoV) und Near Activity Visual Questionnaire (NAVQ) will be used.
Fundus examination with dilated pupil Pre-OP, 1 month postoperative, 12 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:
• FundusSlitlamp examination - Signs of inflammation Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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
* Anterior chamber cells,
* Anterior chamber flare,
* Cystoid macular oedema,
* Hypopyon, and
* EndophthalmitisSlitlamp examination - Retinal detachment Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 detachmentSlitlamp examination - IOL tilt Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 tiltSlitlamp examination - IOL discoloration Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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 discolorationSlitlamp examination - IOL opacity Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 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
Trial Locations
- Locations (1)
Asian Eye Institute
🇵🇭Makati City, Philippines