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

Primary Purpose

Aphakia, Postcataract, Cataract; Eye Disease

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

POD L GF IOL

Symfony® IOL

AcrySof® IOL

About this trial

This is an interventional treatment trial for Aphakia, Postcataract

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

OphtALLIANCE Clinique Jules Verne
Augenklinik Ahaus
Internationale Innovative Ophthalmochirgie
Augentagesklinik Rheine
IOA Madrid Innova Ocular

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

POD L GF

Symfony®

AcrySof®

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

CDVA in first implanted eyes

Photopic monocular logMAR corrected distance visual acuity (CDVA) in first implanted eyes at Visit 4

DCIVA in first implanted eyes

Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA) in first implanted eyes at Visit 4

DCNVA in first implanted eyes

Photopic monocular logMAR near visual acuity with distance correction (DCNVA) in first implanted eyes at Visit 4

Secondary Outcome Measures

UDVA at Visits 3A, 3B, 4, and 5

Photopic monocular logMAR uncorrected distance visual acuity (UDVA)

UIVA at Visits 3A, 3B, 4, and 5

Photopic monocular logMAR uncorrected intermediate visual acuity (UIVA)

UNVA at Visits 3A, 3B, 4, and 5

Photopic monocular logMAR uncorrected near visual acuity (UNVA)

CDVA at Visits 3A, 3B, 4, and 5

Photopic monocular logMAR corrected distance visual acuity (CDVA)

DCIVA at Visits 3A, 3B, 4, and 5

Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA)

DCNVA at Visits 3A, 3B, 4, and 5

Photopic monocular logMAR corrected near visual acuity with distance correction (DCNVA)

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".

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.

Full Information

NCT ID

NCT04005651

First Posted

June 26, 2019

Last Updated

April 18, 2023

Sponsor

Beaver-Visitec International, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04005651

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 30, 2019 (Actual)

Primary Completion Date

July 27, 2022 (Actual)

Study Completion Date

November 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beaver-Visitec International, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphakia, Postcataract, Cataract; Eye Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

POD L GF

Arm Type

Experimental

Arm Description

Arm Title

Symfony®

Arm Type

Active Comparator

Arm Description

Arm Title

AcrySof®

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

POD L GF IOL

Intervention Description

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

Intervention Name(s)

Symfony® IOL

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

AcrySof® IOL

Intervention Description

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

Primary Outcome Measure Information:

Title

CDVA in first implanted eyes

Description

Photopic monocular logMAR corrected distance visual acuity (CDVA) in first implanted eyes at Visit 4

Time Frame

Day 120-180 both eyes

Title

DCIVA in first implanted eyes

Description

Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA) in first implanted eyes at Visit 4

Time Frame

Day 120-180 both eyes

Title

DCNVA in first implanted eyes

Description

Photopic monocular logMAR near visual acuity with distance correction (DCNVA) in first implanted eyes at Visit 4

Time Frame

Day 120-180 both eyes

Secondary Outcome Measure Information:

Title

UDVA at Visits 3A, 3B, 4, and 5

Description

Photopic monocular logMAR uncorrected distance visual acuity (UDVA)

Time Frame