Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT04005651
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2019-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL
Sponsor:
Beaver-Visitec International, Inc.
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: