PHY1703: Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL

Sponsor

Beaver-Visitec International, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03306342

Collaborator

(none)

Enrollment

Location

Arm

33.3

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)

Condition or Disease	Intervention/Treatment	Phase
Cataract Lens Opacities Presbyopia	Device: IOL implantation experimental	N/A

Detailed Description

This clinical investigation is a prospective, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL, Liège, Belgium).

The study purpose is to obtain clinical data on visual acuity, contrast sensitivity, questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF.

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

In total 25 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD F GF intraocular lens.

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 24 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Study to Investigate Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL

Actual Study Start Date :

Feb 2, 2018

Actual Primary Completion Date :

Nov 10, 2020

Actual Study Completion Date :

Nov 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IOL implantation experimental hydrophobic, trifocal intraocular lens POD F GF	Device: IOL implantation experimental Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Arm

Intervention/Treatment

Experimental: IOL implantation experimental

hydrophobic, trifocal intraocular lens POD F GF

Device: IOL implantation experimental

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Outcome Measures

Primary Outcome Measures

binocular Uncorrected Distance Visual Acuity (UDVA) [3 months postoperative]
Statistically significant equality between literature data and data obtained in this study on binocular UDVA. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014

Secondary Outcome Measures

Manifested refraction [3 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)
Uncorrected Distance Visual Acuity (UDVA) [3 months postoperative]
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Corrected Distance Visual Acuity (CDVA) [3 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 and binocularly.
Distance Corrected Intermediate Visual Acuity (DCIVA) [3 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 and binocularly.
Uncorrected Intermediate Visual Acuity (UIVA) [3 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 and binocularly.
Distance Corrected Near Visual Acuity (DCNVA) [3 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 and binocularly.
Uncorrected Near Visual Acuity (UNVA) [3 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 and binocularly.
Contrast Sensitivity [3 months postoperative]
Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Aberrometry [3 months postoperative]
Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
PCO rate [2 years postoperative]
The rate of patients showing posterior capsular opacities (PCO) long term after surgery will be assessed. The criteria is, if the eye requires a secondary treatment to remove the PCO.
questionnaire [3 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 VFQ-25 (National Eye Institute) will be used. The maximum score for each question is 100.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Irregular astigmatism
Age of patient < 45 years
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° in one or both eyes

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 (determined by OCT)
Complicated surgery