Back to resultsClinical Study to Investigate Outcomes of Trifocal Toric IOL POD FT in Asian Eyes
Primary Purpose
Cataract, Lens Opacities, Presbyopia
Status
Active
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
IOL implantation experimental
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, Trifocal, Toric Lens
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Asian Eye Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
POD FT IOL Implantation experimental
Arm Description
Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT and POD F.
Outcomes
Primary Outcome Measures
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
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
Manifested refraction
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)
Pupil Size
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
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
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
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
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.
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular
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.
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular
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.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular
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.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular
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.
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.
Uncorrected Near Visual Acuity at 35cm (UNVA) - monocular
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
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
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
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular
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
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
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
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
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
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
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.
Slitlamp examination - Corneal Status
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
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
Slitlamp examination - Signs of inflammation
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
Slitlamp examination - Pupillary block
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
Slitlamp examination - Retinal detachment
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
Slitlamp examination - Status of anterior and posterior capsule
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
Slitlamp examination - IOL decentration
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
Slitlamp examination - IOL tilt
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
Slitlamp examination - IOL discoloration
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
Slitlamp examination - IOL opacity
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
Photograph of IOL with dilated pupil to asses IOL rotation
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.
Full Information
NCT ID
NCT03844828
First Posted
February 13, 2019
Last Updated
September 29, 2023
Sponsor
Beaver-Visitec International, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03844828
Brief Title
Clinical Study to Investigate Outcomes of Trifocal Toric IOL POD FT in Asian Eyes
Official Title
Clinical Study to Investigate Rotational Stability, Visual Performance, Contrast Sensitivity, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Toric IOL
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
November 22, 2022 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beaver-Visitec International, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Opacities, Presbyopia
Keywords
Intraocular Lens, Trifocal, Toric Lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
POD FT IOL Implantation experimental
Arm Type
Experimental
Arm Description
Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT and POD F.
Intervention Type
Device
Intervention Name(s)
IOL implantation experimental
Other Intervention Name(s)
POD FT IOL implantation
Intervention Description
Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT. If both eyes of the same patient qualify for the implantation of a trifocal toric lens, a bilateral implantation will be performed. If only one eye qualifies for a trifocal toric lens, the contralateral eye will be implanted with the spherical trifocal IOL POD F (both lenses: (PhysIOL, Liège, Belgium).
Primary Outcome Measure Information:
Title
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
Description
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).
Time Frame
6 months (120-180 days) postoperative
Secondary Outcome Measure Information:
Title
Manifested refraction
Description
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)
Time Frame
Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Pupil Size
Description
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.
Time Frame
6 months postoperative
Title
Uncorrected Distance Visual Acuity (UDVA) - monocular
Description
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Uncorrected Distance Visual Acuity (UDVA) - binocular
Description
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Corrected Distance Visual Acuity (CDVA) - monocular
Description
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.
Time Frame
Pre-OP, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Corrected Distance Visual Acuity (CDVA) - binocular
Description
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.
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular
Description
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.
Time Frame
1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular
Description
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.
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular
Description
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.
Time Frame
1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular
Description
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.
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular mesopic.
Description
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.
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Uncorrected Near Visual Acuity at 35cm (UNVA) - monocular
Description
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
Time Frame
1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Uncorrected Near Visual Acuity at 35cm (UNVA) - binocular
Description
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
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
Description
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
Time Frame
1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular
Description
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
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular mesopic
Description
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
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Defocus Curve
Description
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.
Time Frame
6 months postoperative
Title
Binocular Contrast Sensitivity under photopic light conditions
Description
Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Binocular Contrast Sensitivity under mesopic light conditions
Description
Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
Description
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.
Time Frame
6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Patient reported outcomes
Description
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.
Time Frame
6 months postoperative, 12 months postoperative
Title
Slitlamp examination - Corneal Status
Description
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
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Fundus examination with dilated pupil
Description
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
Time Frame
Pre-OP, 1 month postoperative, 12 months postoperative
Title
Slitlamp examination - Signs of inflammation
Description
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
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Slitlamp examination - Pupillary block
Description
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
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Slitlamp examination - Retinal detachment
Description
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
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Slitlamp examination - Status of anterior and posterior capsule
Description
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
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Slitlamp examination - IOL decentration
Description
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
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Slitlamp examination - IOL tilt
Description
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
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Slitlamp examination - IOL discoloration
Description
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
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Slitlamp examination - IOL opacity
Description
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
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Photograph of IOL with dilated pupil to asses IOL rotation
Description
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.
Time Frame
OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other Pre-specified Outcome Measures:
Title
Intraocular pressure (IOP) measurement
Description
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.
Time Frame
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Title
Keratometry
Description
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.
Time Frame
Pre-OP
Title
Biometry
Description
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.
Time Frame
Pre-OP
Title
IOL power and target refraction
Description
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.
Time Frame
Operative (day of Surgery)
Title
Fundus OCT
Description
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.
Time Frame
Pre-OP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Edward Ang, MD
Organizational Affiliation
Asian Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asian Eye Institute
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study to Investigate Outcomes of Trifocal Toric IOL POD FT in Asian Eyes
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