Clinical trial NCT04005651: Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia, Postcataract
Cataract; Eye Disease
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Approximately 150 subjects will be implanted bilaterally with 50 subjects implanted with the POD L GF lenses, 50 subjects implanted with the Symfony® intraocular lenses, and 50 subjects implanted with the AcrySof® monofocal lenses. The objective is to complete approximately 141 subjects through 12 month post-operative follow-up (\~47 subjects in each cohort).
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: CDVA in first implanted eyes
timeFrame: Day 120-180 both eyes
measure: DCIVA in first implanted eyes
timeFrame: Day 120-180 both eyes
measure: DCNVA in first implanted eyes
timeFrame: Day 120-180 both eyes
Secondary outcomes:
measure: UDVA at Visits 3A, 3B, 4, and 5
timeFrame: 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)
measure: UIVA at Visits 3A, 3B, 4, and 5
timeFrame: 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)
measure: UNVA at Visits 3A, 3B, 4, and 5
timeFrame: 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)
measure: CDVA at Visits 3A, 3B, 4, and 5
timeFrame: 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)
measure: DCIVA at Visits 3A, 3B, 4, and 5
timeFrame: 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)
measure: DCNVA at Visits 3A, 3B, 4, and 5
timeFrame: 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)
measure: Quality of Vision Questionnaire (QoV) quality of vision at Visit 4
timeFrame: Day 120-180 both eyes
measure: Near Activity Visual Questionnaire (NAVQ) quality of vision at Visit 4
timeFrame: Day 120-180 both eyes
Other outcomes:
measure: Safety Endpoint: Rates of AEs (Adverse Events)
timeFrame: Enrollment (Day -30 to -1) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first
measure: Safety Endpoint: Optical and Visual Symptoms Assessed with NAVQ
timeFrame: Visit 4 (Day 120 to 180 both eyes)
measure: Safety Endpoint: Optical and Visual Symptoms Assessed with QoV questionnaire
timeFrame: Visit 4 (Day 120 to 180 both eyes)
measure: Safety Endpoint: Secondary Surgical Interventions
timeFrame: Operative Visit (Day 0) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first
measure: Safety Endpoint: Serious Adverse Events
timeFrame: Day 330 to 420 both eyes
Locations:
city: Nantes
country: France
facility: OphtALLIANCE Clinique Jules Verne
city: Ahaus
country: Germany
facility: Augenklinik Ahaus
city: Düsseldorf
country: Germany
facility: Internationale Innovative Ophthalmochirgie
city: Rheine
country: Germany
facility: Augentagesklinik Rheine
city: Madrid
country: Spain
facility: IOA Madrid Innova Ocular
Study officials:
affiliation: PhysIOL s.a.
name: Christophe Pagnoulle
role: STUDY_DIRECTOR
References: