Comparison of Clinical Outcomes POD L GF vs POD F GF (PHY1707)

Beaver-Visitec International, Inc.53 enrolled

Overview

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.

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 L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium). The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). 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 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically. Primary and secondary endpoint data will be collected at the 6 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract Lens Opacity Presbyopia

Interventions

IOL implantation experimentalDEVICE

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> intermediate \> near

IOL implantation comparatorDEVICE

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> near \> intermediate

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Cataractous eyes and/or patients suffering from presbyopia with no ocular comorbidity * Availability, willingness and sufficient cognitive awareness to comply with examination procedures * Signed informed consent Exclusion Criteria: * Age of patient \<40 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) * AMD suspicious eyes * Complicated surgery

Locations (1)

Semmelweis University - Department of Ophthalmology

Budapest, Hungary

Outcomes

Primary Outcomes

Monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.

No statistically significant difference between the two study groups on monocular CDVA at 3 months follow up visit. A significance level of 0.05 or lower (p \< 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014.

Time frame: 3 months postoperative

Secondary Outcomes

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)

Time frame: 3 months postoperative

Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.

Time frame: 3 months postoperative

Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions

UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.

Time frame: 6 months postoperative

Corrected Distance Visual Acuity (CDVA) under photopic light conditions

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 light conditions.

Time frame: 3 months postoperative

Corrected Distance Visual Acuity (CDVA) under mesopic light conditions

Data from ClinicalTrials.gov

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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 mesopic light conditions.

Time frame: 6 months postoperative

Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under photopic light conditions

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 and binocularly under photopic light conditions.

Time frame: 3 months postoperative

Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under mesopic light conditions

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 light conditions.

Time frame: 6 months postoperative

Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under photopic light conditions

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 and binocularly under photopic light conditions.

Time frame: 3 months postoperative

Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under mesopic light conditions

Time frame: 6 months postoperative

Distance Corrected Near Visual Acuity at 35cm (DCNVA) under photopic light conditions

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 and binocularly under photopic light conditions.

Time frame: 3 months postoperative

Distance Corrected Near Visual Acuity at 35cm (DCNVA) under mesopic light conditions

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 light conditions.

Time frame: 6 months postoperative

Uncorrected Near Visual Acuity at 35cm (UNVA) under photopic light conditions

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 and binocularly under photopic light conditions.

Time frame: 3 months postoperative

Uncorrected Near Visual Acuity at 35cm (UNVA) under mesopic light conditions

Time frame: 6 months postoperative

Contrast Sensitivity (monocular)

Contrast Sensitivity under photopic and mesopic light conditions

Time frame: 6 months postoperative

Contrast Sensitivity (binocular)

Contrast Sensitivity under photopic and mesopic light conditions

Time frame: 3 months postoperative

Questionnaire: Visual Functioning Questionnaire - 25 (VFQ-25, National Eye Institute)

Patient reported 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 VFQ-25 (National Eye Institute) will be used. This questionnaire consists of 25 questions. Each answer is scaled between a score of 0 and 100 according to a predefined calculation algorithm, with 100 always being the best possible outcome. Additionally subscales are calculated as an average value of several answers belonging to the same set of questions. The subscales are: * General Health * General Vision * Ocular Pain * Near Activities * Distance Activities * Social Functioning * Mental Health * Role Difficulties * Dependancy * Driving * Color Vision * Peripheral Vision

Time frame: 3 months postoperative

Defocus Curve monocular

To assess the visual acuity for different distances, defocus curves under photopic and mesopic 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.

Time frame: 1 month postoperative

Defocus Curve binocular

Time frame: 3 months postoperative