Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL

Post-Market Follow-up Clinical Trial to Investigate Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF In Comparison With a Multifocal (TECNIS Symfony® Extended Range of Vision IOL) and a Monofocal (AcrySof® IQ Monofocal IOL)

The objectives of the Post-Market Follow-up (PMCF) clinical investigation are to determine the safety and performance of a hydrophobic trifocal intraocular lens POD L GF in comparison with two comparator lenses: another multifocal intraocular lens (Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL); and a monofocal intraocular lens (Alcon AcrySof® IQ Monofocal IOL) through one year of post-operative assessments.

Study Overview

• Status: Completed
• Conditions: Aphakia, Postcataract; Cataract; Eye Disease
• Intervention / Treatment: Device: POD L GF IOL; Device: Symfony® IOL; Device: AcrySof® IOL

Detailed Description

This is a prospective, multicenter, randomized, active controlled comparative binocular Post Market Follow-up (PMCF) clinical study to demonstrate safety and efficacy between the trifocal intraocular lens POD L GF and the Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL and the Alcon AcrySof® IQ Monofocal IOL.

Patients who are scheduled to undergo cataract extraction in one or both eyes and posterior chamber intraocular lens implants may be screened for eligibility in the study and, if eligible, complete a pre-operative screening visit. Both eyes of subjects who are eligible to receive the POD L GF IOL or the Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL must be eligible to receive bilateral multifocal IOL implants. Both eyes of subjects who are eligible to receive the Alcon AcrySof® IQ Monofocal IOL must be eligible to receive bilateral monofocal IOL implants.

At the time of the first eye surgery, the subjects to be implanted with either the POD L GF (test) IOL or the Johnson & Johnson TECNIS Symfony® Extended Range of Vision (comparator) IOL will be randomized to receive either the test or comparator IOL in a 1:1 ratio. In addition, 50 subjects will be implanted with the Alcon AcrySof® IQ Monofocal IOL. All subjects will undergo bilateral IOL implantation and will receive the same brand of lenses in each eye. Second eye implantations will be delayed until 1 to 30 days after the first eye implantation.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jochen Kandulla; Phone Number: +49 157 862 75 281; Email: J.Kandulla@physiol.be
• Study Contact Backup: Name: Rebecca McQuaid; Phone Number: +32 04 361 45 32; Email: r.mcquaid@physiol.be

Study Locations

• France
  • Nantes, France, 44300
    • OphtALLIANCE Clinique Jules Verne
• Germany
  • Ahaus, Germany, 48683
    • Augenklinik Ahaus
  • Düsseldorf, Germany, 40212
    • Internationale Innovative Ophthalmochirgie
  • Rheine, Germany, 48429
    • Augentagesklinik Rheine
• Spain
  • Madrid, Spain, 28003
    • IOA Madrid Innova Ocular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female adults ages 45 or older on the day of screening who have cataract(s) in one or both eyes
• Capability to understand and sign an Ethics Committee (EC) approved informed consent form and privacy authorization
• Corrected visual acuity projected by potential acuity meter (PAM) testing or other potential visual acuity test procedure to be better than 20/32 after intraocular lens implantation
• Clear intraocular media other than cataract
• Calculated IOL power is within the range of the study IOLs
• Dilated pupil size large enough to visualize IOL axis markings postoperatively
• Willing and able to conform to the study requirements

Exclusion Criteria:

• Subjects with diagnosed degenerative visual disoerders (e.g., macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
• Subjects with age-related macular degeneration (AMD) suspicious eyes as determined by optical coherence tomography (OCT) examination
• Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema
• Greater than 1 diopter of pre-operative corneal astigmatism or any irregular astigmatism
• Previous intraocular or corneal surgery
• Traumatic cataract
• History or presence of macular edema
• Pregnant,lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study
• Concurrent or previous (within 30 days) participation in another drug or device investigation
• Instability of keratometry or biometry measurements
• Ocular hypertension or glaucoma
• Significant dry eye
• Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgement (reason to be documented on eCRF)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POD L GF; Approximately 50 subjects who are scheduled for multifocal IOL implantation and enrolled in the study will be randomized into the POD L GF arm. Subjects will be implanted bilaterally with the European Conformity (CE) marked POD L GF trifocal IOL and assessed according to the study visit schedule.	Device: POD L GF IOL; Cataractous lens will be removed in the study eyes and the POD L GF IOL will be implanted in the capsular bag
Active Comparator: Symfony®; Approximately 50 subjects who are scheduled for multifocal IOL implantation and enrolled in the study will be randomized into the Symfony arm. Subjects will be implanted bilaterally with the CE marked TECNIS Symfony® IOL and assessed according to the study visit schedule.	Device: Symfony® IOL; Cataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag
Active Comparator: AcrySof®; Approximately 50 subjects who are scheduled for monofocal IOL implantation and enrolled in the study will be placed in the AcrySof® arm. Subjects will be implanted bilaterally with the CE marked AcrySof® IQ monofocal IOL and assessed according to the study visit schedule.	Device: AcrySof® IOL; Cataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDVA in first implanted eyes	Photopic monocular logMAR corrected distance visual acuity (CDVA) in first implanted eyes at Visit 4	Day 120-180 both eyes
DCIVA in first implanted eyes	Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA) in first implanted eyes at Visit 4	Day 120-180 both eyes
DCNVA in first implanted eyes	Photopic monocular logMAR near visual acuity with distance correction (DCNVA) in first implanted eyes at Visit 4	Day 120-180 both eyes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDVA at Visits 3A, 3B, 4, and 5	Photopic monocular logMAR uncorrected distance visual acuity (UDVA)	Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
UIVA at Visits 3A, 3B, 4, and 5	Photopic monocular logMAR uncorrected intermediate visual acuity (UIVA)	Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
UNVA at Visits 3A, 3B, 4, and 5	Photopic monocular logMAR uncorrected near visual acuity (UNVA)	Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
CDVA at Visits 3A, 3B, 4, and 5	Photopic monocular logMAR corrected distance visual acuity (CDVA)	Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
DCIVA at Visits 3A, 3B, 4, and 5	Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA)	Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
DCNVA at Visits 3A, 3B, 4, and 5	Photopic monocular logMAR corrected near visual acuity with distance correction (DCNVA)	Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5)
Quality of Vision Questionnaire (QoV) quality of vision at Visit 4	Quality of vision based on response to each question in the Quality of Vision (QoV) questionnaire at Visit 4. Answer is a choice of 4 options, the first being the least and the fourth being the most based on question type, i.e. "never" to "very often" or "not at all" to "severe".	Day 120-180 both eyes
Near Activity Visual Questionnaire (NAVQ) quality of vision at Visit 4	Quality of vision based on response (choice of 0-3 with 0 meaning no difficulty and 3 meaning extreme difficulty) to each question in the Near Activity Visual Questionnaire (NAVQ) at Visit 4.	Day 120-180 both eyes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint: Rates of AEs (Adverse Events)	Rates of posterior chamber IOL adverse events compared to the ISO Safety and Performance Endpoint (SPE) rates as described in International Organization for Standardization (ISO) 11979-7	Enrollment (Day -30 to -1) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first
Safety Endpoint: Optical and Visual Symptoms Assessed with NAVQ	Subject questionnaire frequency of optical and visual symptoms as reported in NAVQ	Visit 4 (Day 120 to 180 both eyes)
Safety Endpoint: Optical and Visual Symptoms Assessed with QoV questionnaire	Subject questionnaire frequency of optical and visual symptoms as reported in QOV questionnaire	Visit 4 (Day 120 to 180 both eyes)
Safety Endpoint: Secondary Surgical Interventions	Rates of device-related secondary surgical interventions related to the POD L GF trifocal IOL	Operative Visit (Day 0) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first
Safety Endpoint: Serious Adverse Events	The rate of serious adverse events related to teh POD L GF trifocal IOL in first implanted eyes through Visit 5	Day 330 to 420 both eyes

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.
• Investigators: Study Director: Christophe Pagnoulle, PhysIOL s.a.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lens Diseases; Eye Diseases; Cataract; Aphakia; Aphakia, Postcataract
• Other Study ID Numbers: PHY1804

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
• product manufactured in and exported from the U.S.: No