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

Cataract Clinical Trial

— PHY1706  

Official title:

Clinical Study to Compare Clinical Outcomes of IOLs FineVision POD F GF (Hydrophobic) and FineVision POD F (Hydrophilic) After Bilateral Implantation in Asian Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306355
• Other study ID #: PHY 1706
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: February 10, 2022

Study information

• Verified date: July 2023
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

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

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 10, 2022
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Cataractous eyes with no comorbidity

• Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.

• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

• Signed informed consent

Exclusion Criteria:

• Unrealistic expectation

• Age of patient <45 years

• Irregular astigmatism

• Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°

• Difficulty for cooperation (distance from their home, general health condition)

• Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)

• Any ocular comorbidity

• History of ocular trauma or prior ocular surgery including refractive procedures

• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)

• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)

• Age-related Macular Degeneration (AMD) suspicious eyes (determined by OCT)

• Complicated surgery

Related Conditions & MeSH terms

• Cataract
• Lens Opacities
• Presbyopia

Intervention

Device:
• IOL implantation experimental
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
• IOL implantation active comparator
Implantation of trifocal IOL POD F consisting of hydrophilic material

Locations

Country	Name	City	State
Philippines	Asian Eye Institute	Makati City

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraocular pressure (IOP) measurement	The IOP will be measured with non-contact tonometer as part of the routine follow up examinations	Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Other	Keratometry	Keratometric measurements are performed to calculate the required IOL power	Pre-OP
Other	Biometry	Biometry measurements are performed to calculate the required IOL power	Pre-OP
Primary	Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.	No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014	3 months postoperative
Secondary	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)	Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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.	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	Uncorrected Near Visual Acuity at 35cm (UNVA)	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.	1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	Uncorrected Near Visual Acuity at 35cm (UNVA)	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.	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	Contrast Sensitivity	Contrast Sensitivity under photopic and mesopic light conditions	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	Aberrometry	Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	AcuTarget diagnostic device	Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	Visual Functioning Questionnaire - 25 (VFQ-25)	Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified Visual Functioning Questionnaire - 25 (VFQ-25) will be used. The maximum score for each questionaire is 100.	3 months postoperative, 12 months postoperative.
Secondary	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 monocularly and binocularly.	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	Slitlamp examination - Fundus	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Secondary	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	3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.