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

Aphakia, Postcataract Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005651
• Other study ID #: PHY1804
• Status: Completed
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: November 29, 2022

Study information

• Verified date: April 2023
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 a monofocal intraocular lens (Alcon AcrySof® IQ Monofocal IOL) through one year of post-operative assessments.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 29, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aphakia
• Aphakia, Postcataract
• Cataract
• Cataract; Eye Disease
• Eye Diseases

Intervention

Device:
• POD L GF IOL
Cataractous lens will be removed in the study eyes and the POD L GF IOL will be implanted in the capsular bag
• Symfony® IOL
Cataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag
• AcrySof® IOL
Cataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag

Locations

Country	Name	City	State
France	OphtALLIANCE Clinique Jules Verne	Nantes
Germany	Augenklinik Ahaus	Ahaus
Germany	Internationale Innovative Ophthalmochirgie	Düsseldorf
Germany	Augentagesklinik Rheine	Rheine
Spain	IOA Madrid Innova Ocular	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)
Other	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)
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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)
Secondary	UIVA at Visits 3A, 3B, 4, and 5	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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