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

NCT ID: NCT04005651

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2022-11-29

Brief Summary

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.

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.

Conditions

Aphakia, Postcataract; Cataract; Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

POD L GF IOL

Intervention Type: DEVICE

Cataractous lens will be removed in the study eyes and the POD L GF IOL will be implanted in the capsular bag

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.

Group Type: ACTIVE_COMPARATOR

Symfony® IOL

Intervention Type: DEVICE

Cataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag

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.

Group Type: ACTIVE_COMPARATOR

AcrySof® IOL

Intervention Type: DEVICE

Cataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag

Interventions

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

Intervention Type: DEVICE

Symfony® IOL

Cataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag

Intervention Type: DEVICE

AcrySof® IOL

Cataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Pagnoulle

Role: STUDY_DIRECTOR

PhysIOL s.a.

Locations

OphtALLIANCE Clinique Jules Verne

Nantes, , France

Augenklinik Ahaus

Ahaus, , Germany

Internationale Innovative Ophthalmochirgie

Düsseldorf, , Germany

Augentagesklinik Rheine

Rheine, , Germany

IOA Madrid Innova Ocular

Madrid, , Spain

Countries

France; Germany; Spain

Other Identifiers

PHY1804

Identifier Type: -

Identifier Source: org_study_id