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

Cataract Clinical Trial

— PHY1703  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306342
• Other study ID #: PHY 1703
• Status: Completed
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: November 11, 2020

Study information

• Verified date: January 2022
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 11, 2020
• Est. primary completion date: November 10, 2020
• 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:

• 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

Related Conditions & MeSH terms

• Cataract
• Lens Opacities
• Presbyopia

Intervention

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

Locations

Country	Name	City	State
France	Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis	Brest

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	binocular Uncorrected Distance Visual Acuity (UDVA)	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	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)	3 months postoperative
Secondary	Uncorrected Distance Visual Acuity (UDVA)	UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.	3 months postoperative
Secondary	Corrected Distance Visual Acuity (CDVA)	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.	3 months postoperative
Secondary	Distance Corrected Intermediate Visual Acuity (DCIVA)	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.	3 months postoperative
Secondary	Uncorrected Intermediate Visual Acuity (UIVA)	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.	3 months postoperative
Secondary	Distance Corrected Near Visual Acuity (DCNVA)	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.	3 months postoperative
Secondary	Uncorrected Near Visual Acuity (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 and binocularly.	3 months postoperative
Secondary	Contrast Sensitivity	Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)	3 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
Secondary	PCO rate	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.	2 years postoperative
Secondary	questionnaire	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.	3 months postoperative