Aphakia, PostcataractNCT04005651
Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL
A study testing POD L GF IOL, Symfony® IOL and AcrySof® IOL in people with Aphakia, Postcataract and Cataract; Eye Disease, run by Beaver-Visitec International, Inc. at 5 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Aphakia, Postcataract, Cataract; Eye Disease
- What is being tested?
- POD L GF IOL, Symfony® IOL and AcrySof® IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 30 May 2019to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
Augenklinik Ahaus
Ahaus, 48683
Internationale Innovative Ophthalmochirgie
Düsseldorf, 40212
Augentagesklinik Rheine
Rheine, 48429
About this study
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)
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.
Read the 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
- Being tested
- POD L GF IOL, Symfony® IOL, AcrySof® IOL
- Medical subject headings
- Aphakia, Postcataract, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POD L GF IOLDevice
Cataractous lens will be removed in the study eyes and the POD L GF IOL will be implanted in the capsular bag
Symfony® IOLDevice
Cataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag
AcrySof® IOLDevice
Cataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: AcrySof® IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDVA in first implanted eyes
Photopic monocular logMAR corrected distance visual acuity (CDVA) in first implanted eyes at Visit 4
Measured: 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
Measured: 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
Measured: Day 120-180 both eyes
Secondary outcomes (8)
UDVA at Visits 3A, 3B, 4, and 5
Photopic monocular logMAR uncorrected distance visual acuity (UDVA)
Measured: 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
Photopic monocular logMAR uncorrected intermediate visual acuity (UIVA)
Measured: 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
Photopic monocular logMAR uncorrected near visual acuity (UNVA)
Measured: 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
Photopic monocular logMAR corrected distance visual acuity (CDVA)
Measured: 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
Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA)
Measured: 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)
DCNVA at Visits 3A, 3B, 4, and 5
Photopic monocular logMAR corrected near visual acuity with distance correction (DCNVA)
Measured: 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)
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".
Measured: Day 120-180 both eyes
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.
Measured: Day 120-180 both eyes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start30 May 2019
- Primary completion27 Jul 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphakia, PostcataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Pagnoulle, Study director, PhysIOL s.a.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005651
- Sponsor's protocol ID
- PHY1804
- Status last verified
- Apr 2023
- First submitted
- 26 Jun 2019
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04005651
- Acronym / sponsor ID
- PHY1804
- Conditions
- Aphakia, Postcataract, Cataract; Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| POD L GF | Experimental | Device: POD L GF IOLApproximately 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. |
| Symfony® | Active comparator | Device: Symfony® IOLApproximately 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. |
| AcrySof® | Active comparator | Device: AcrySof® IOLApproximately 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POD L GF IOLCataractous lens will be removed in the study eyes and the POD L GF IOL will be implanted in the capsular bag | Device | POD L GF |
| Symfony® IOLCataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag | Device | Symfony® |
| AcrySof® IOLCataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag | Device | AcrySof® |
Primary outcome
CDVA in first implanted eyes
Time frame: Day 120-180 both eyes
Photopic monocular logMAR corrected distance visual acuity (CDVA) in first implanted eyes at Visit 4
DCIVA in first implanted eyes
Time frame: Day 120-180 both eyes
Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA) in first implanted eyes at Visit 4
DCNVA in first implanted eyes
Time frame: Day 120-180 both eyes
Photopic monocular logMAR near visual acuity with distance correction (DCNVA) in first implanted eyes at Visit 4
8 secondary outcomes
UDVA at Visits 3A, 3B, 4, and 5
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)
UIVA at Visits 3A, 3B, 4, and 5
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)
UNVA at Visits 3A, 3B, 4, and 5
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)
CDVA at Visits 3A, 3B, 4, and 5
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)
DCIVA at Visits 3A, 3B, 4, and 5
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)
DCNVA at Visits 3A, 3B, 4, and 5
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)
Quality of Vision Questionnaire (QoV) quality of vision at Visit 4
Time frame: Day 120-180 both eyes
Near Activity Visual Questionnaire (NAVQ) quality of vision at Visit 4
Time frame: Day 120-180 both eyes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Pagnoulle study director
PhysIOL s.a.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POD L GF IOL, Symfony® IOL and AcrySof® IOL in people with Aphakia, Postcataract and Cataract; Eye Disease, run by Beaver-Visitec International, Inc. at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDVA in first implanted eyes (time frame: Day 120-180 both eyes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.