Clinical Study to Compare Visual Performance of Two Trifocal IOLs (PHY1702)

Clinical Study to Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)

Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia; Lens Opacities
• Intervention / Treatment: Device: IOL implantation experimental; Device: IOL implantation active comparator

Detailed Description

This is a prospective, randomised, 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. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F.

The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 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. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28003
    • Innova Ocular IOA Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 < 50 years
• Regular corneal astigmatism >1.00 dioptres by an automatic keratometer or biometer or >1.25 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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
ACTIVE_COMPARATOR: IOL implantation active comparator; hydrophilic, trifocal intraocular lens POD F	Device: IOL implantation active comparator; Implantation of trifocal IOL POD F consisting of hydrophilic material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.	The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular 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	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manifested refraction - Sphere	The spherical part of the manifested refraction is measured by means of a phoropter. The examination is done according to ISO 11979-7:2014.	3 months postoperative
Manifested refraction - Cylinder	The cylindrical part of the manifested refraction is measured by means of a phoropter. Amount of cylinder and cylinder axis will be noted. The examination is done according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)	3 months postoperative
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 binocularly.	3 months postoperative
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
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA)	DCIVA is measured with Radner reading charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.	3 months postoperative
Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA)	DCIVA is measured with ETDRS charts placed in 63cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.	3 months postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA)	DCNVA is measured with Radner reading charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.	3 months postoperative
Distance Corrected Near Visual Acuity at 25cm (DCNVA)	DCNVA is measured with Radner reading charts placed in 25cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.	3 months postoperative
Halometry	Halometry outcomes, measurement by halos software v1.0	3 months postoperative
Contrast Sensitivity	Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)	3 months postoperative
Aberrometry - SA	Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: Spherical aberration	3 months postoperative
Aberrometry - HOA	Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: High Order Aberrations	3 months postoperative
Aberrometry - Tilt	Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: lens tilt	3 months postoperative
OQAS II - OSI	Outcomes of OQAS II diagnostic device (Ocular Scatter Index)	3 months postoperative
OQAS II - MTF	Outcomes of OQAS II diagnostic device (Modular Transfer Function)	3 months postoperative
OQAS II - Strehl Ratio	Outcomes of OQAS II diagnostic device (Strehl Ratio)	3 months postoperative
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. The scoring and evaluation of the questionnaire will be done according to the official guidelines and manual provided by National Eye Institute	3 months postoperative

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.
• Investigators: Principal Investigator: Francisco Poyales Galan, MD, Innova Ocular IOA Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2017
• Primary Completion (ACTUAL): May 21, 2019
• Study Completion (ACTUAL): May 21, 2019

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (ACTUAL): November 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Intraocular Lens; hydrophobic; trifocal; hydrophilic
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: PHY1702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No