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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| UDVA at Visits 3A, 3B, 4, and 5 | Photopic monocular logMAR uncorrected distance visual acuity (UDVA) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint: Rates of AEs (Adverse Events) | 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 | Enrollment (Day -30 to -1) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Pagnoulle | PhysIOL s.a. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OphtALLIANCE Clinique Jules Verne | Nantes | 44300 | France | |||
| Augenklinik Ahaus |
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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).
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| Symfony® IOL | Device | Cataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag |
|
| AcrySof® IOL | Device | Cataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag |
|
Photopic monocular logMAR uncorrected intermediate visual acuity (UIVA)
| 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) | 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) | 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) | 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) | 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". | 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. | Day 120-180 both eyes |
| Safety Endpoint: Optical and Visual Symptoms Assessed with NAVQ |
Subject questionnaire frequency of optical and visual symptoms as reported in NAVQ |
| Visit 4 (Day 120 to 180 both eyes) |
| Safety Endpoint: Optical and Visual Symptoms Assessed with QoV questionnaire | Subject questionnaire frequency of optical and visual symptoms as reported in QOV questionnaire | Visit 4 (Day 120 to 180 both eyes) |
| Safety Endpoint: Secondary Surgical Interventions | Rates of device-related secondary surgical interventions related to the POD L GF trifocal IOL | Operative Visit (Day 0) through study exit or Visit 5 (Day 330 to 420 both eyes), whichever comes first |
| Safety Endpoint: Serious Adverse Events | The rate of serious adverse events related to teh POD L GF trifocal IOL in first implanted eyes through Visit 5 | Day 330 to 420 both eyes |
| Ahaus |
| 48683 |
| Germany |
| Internationale Innovative Ophthalmochirgie | Düsseldorf | 40212 | Germany |
| Augentagesklinik Rheine | Rheine | 48429 | Germany |
| IOA Madrid Innova Ocular | Madrid | 28003 | Spain |
| ID | Term |
|---|---|
| D001036 | Aphakia, Postcataract |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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