search
Back to results

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
Sponsored by
Beaver-Visitec International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
June 26, 2019
Last Updated
April 18, 2023
Sponsor
Beaver-Visitec International, Inc.
search

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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

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
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.
Arm Title
Symfony®
Arm Type
Active Comparator
Arm Description
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.
Arm Title
AcrySof®
Arm Type
Active Comparator
Arm Description
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.
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
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)
Title
UIVA at Visits 3A, 3B, 4, and 5
Description
Photopic monocular logMAR uncorrected intermediate visual acuity (UIVA)
Time Frame
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)
Title
UNVA at Visits 3A, 3B, 4, and 5
Description
Photopic monocular logMAR uncorrected near visual acuity (UNVA)
Time Frame
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)
Title
CDVA at Visits 3A, 3B, 4, and 5
Description
Photopic monocular logMAR corrected distance visual acuity (CDVA)
Time Frame
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)
Title
DCIVA at Visits 3A, 3B, 4, and 5
Description
Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA)
Time Frame
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)
Title
DCNVA at Visits 3A, 3B, 4, and 5
Description
Photopic monocular logMAR corrected near visual acuity with distance correction (DCNVA)
Time Frame
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)
Title
Quality of Vision Questionnaire (QoV) quality of vision at Visit 4
Description
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".
Time Frame
Day 120-180 both eyes
Title
Near Activity Visual Questionnaire (NAVQ) quality of vision at Visit 4
Description
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.
Time Frame
Day 120-180 both eyes
Other Pre-specified Outcome Measures:
Title
Safety Endpoint: Rates of AEs (Adverse Events)
Description
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
Time Frame
Enrollment (Day -30 to -1) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first
Title
Safety Endpoint: Optical and Visual Symptoms Assessed with NAVQ
Description
Subject questionnaire frequency of optical and visual symptoms as reported in NAVQ
Time Frame
Visit 4 (Day 120 to 180 both eyes)
Title
Safety Endpoint: Optical and Visual Symptoms Assessed with QoV questionnaire
Description
Subject questionnaire frequency of optical and visual symptoms as reported in QOV questionnaire
Time Frame
Visit 4 (Day 120 to 180 both eyes)
Title
Safety Endpoint: Secondary Surgical Interventions
Description
Rates of device-related secondary surgical interventions related to the POD L GF trifocal IOL
Time Frame
Operative Visit (Day 0) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first
Title
Safety Endpoint: Serious Adverse Events
Description
The rate of serious adverse events related to teh POD L GF trifocal IOL in first implanted eyes through Visit 5
Time Frame
Day 330 to 420 both eyes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Pagnoulle
Organizational Affiliation
PhysIOL s.a.
Official's Role
Study Director
Facility Information:
Facility Name
OphtALLIANCE Clinique Jules Verne
City
Nantes
ZIP/Postal Code
44300
Country
France
Facility Name
Augenklinik Ahaus
City
Ahaus
ZIP/Postal Code
48683
Country
Germany
Facility Name
Internationale Innovative Ophthalmochirgie
City
Düsseldorf
ZIP/Postal Code
40212
Country
Germany
Facility Name
Augentagesklinik Rheine
City
Rheine
ZIP/Postal Code
48429
Country
Germany
Facility Name
IOA Madrid Innova Ocular
City
Madrid
ZIP/Postal Code
28003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs