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

NCT04005651 | Completed

• 1 other identifier: PHY1804
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 5

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.

Conditions

Aphakia, Postcataract; Cataract; Eye Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• UDVA at Visits 3A, 3B, 4, and 5

  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

  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

  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

  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

  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)

Other Outcomes (5)

• Safety Endpoint: Rates of AEs (Adverse Events)

  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

  Visit 4 (Day 120 to 180 both eyes)

• Safety Endpoint: Optical and Visual Symptoms Assessed with QoV questionnaire

  Visit 4 (Day 120 to 180 both eyes)

Study Arms (3)

POD L GF

EXPERIMENTAL

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

Symfony®

ACTIVE COMPARATOR

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

AcrySof®

ACTIVE COMPARATOR

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

Interventions

POD L GF IOL DEVICE

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

POD L GF

Symfony® IOL DEVICE

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

Symfony®

AcrySof® IOL DEVICE

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

AcrySof®

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

Study Sites (5)

OphtALLIANCE Clinique Jules Verne

Nantes, 44300, France

Location

Augenklinik Ahaus

Ahaus, 48683, Germany

Location

Internationale Innovative Ophthalmochirgie

Düsseldorf, 40212, Germany

Location

Augentagesklinik Rheine

Rheine, 48429, Germany

Location

IOA Madrid Innova Ocular

Madrid, 28003, Spain

Location

MeSH Terms

Conditions

Aphakia, Postcataract; Cataract

Condition Hierarchy (Ancestors)

Aphakia; Lens Diseases; Eye Diseases

Study Officials

• Christophe Pagnoulle

  PhysIOL s.a.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 2, 2019
• Study Start: May 30, 2019
• Primary Completion: July 27, 2022
• Study Completion: November 29, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); ES (1); FR (1)