Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06041139
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2022-07-13
Brief Title:
Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
Sponsor:
Berkeley Eye Center
Organization:
Berkeley Eye Center
Study Overview
Official Title:
Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Background
The Tecnis Synergy intraocular lens IOL has a claim to allow patients to experience continuous high-contrast vision from far through near even in low-light conditions
A JJ-sponsored post marketing study done outside of the US claim superiority of range of vision for the Tecnis Synergy IOL over the PanOptix IOL
Hypothesis
Patients with bilateral Panoptix IOLs have non-inferior distance intermediate and near visual acuity compared to patients with bilateral Synergy IOLs in both photopic and mesopic conditions with less glare haloes andor starbursts
Unmet Medical Need
There is a need to look at patient visual outcomes and the visual disturbance profile comparing trifocal technology with combined EDOFBifocal technology in the United States
The Tecnis Synergy intraocular lens IOL has a claim to allow patients to experience continuous high-contrast vision from far through near even in low-light conditions
A JJ-sponsored post marketing study done outside of the US claim superiority of range of vision for the Tecnis Synergy IOL over the PanOptix IOL
Hypothesis
Patients with bilateral Panoptix IOLs have non-inferior distance intermediate and near visual acuity compared to patients with bilateral Synergy IOLs in both photopic and mesopic conditions with less glare haloes andor starbursts
Unmet Medical Need
There is a need to look at patient visual outcomes and the visual disturbance profile comparing trifocal technology with combined EDOFBifocal technology in the United States
Detailed Description:
This is a non-interventional single center two-arm comparative study of the outcomes for patients following successful uncomplicated cataract surgery
There will be 155 subjects enrolled in each arm 310 subjects total
Consecutive screening will be used for enrollment beginning from the first bilateral IOL implanted
All testing will be at a single site with subjects coming from 4 surgeons all use similar surgical technique at that site
Each surgeon will contribute a minimum of ten subjects per arm
Subjects will be assessed post-operatively during a minimum of five months after their second-eye surgery
Binocular defocus curves will be performed from 100 to -400 in 050 diopter steps and with 025 and -025 added
Self-reporting of visual complaints will be assessed
IOLSAT IOL Satisfaction and QUVID Quality of Vision After Surgery questionnaire will be administered at the study visit
Halo and Glare simulator VS Halo Glare visu-medcom will be administered at the study visit
All visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked
PanOptix subjects will have been implanted with the toric and non-toric models
Synergy subjects will have been implanted with the toric and non-toric models
Demographic data will be collected to match the groups as closely as possible
There will be 155 subjects enrolled in each arm 310 subjects total
Consecutive screening will be used for enrollment beginning from the first bilateral IOL implanted
All testing will be at a single site with subjects coming from 4 surgeons all use similar surgical technique at that site
Each surgeon will contribute a minimum of ten subjects per arm
Subjects will be assessed post-operatively during a minimum of five months after their second-eye surgery
Binocular defocus curves will be performed from 100 to -400 in 050 diopter steps and with 025 and -025 added
Self-reporting of visual complaints will be assessed
IOLSAT IOL Satisfaction and QUVID Quality of Vision After Surgery questionnaire will be administered at the study visit
Halo and Glare simulator VS Halo Glare visu-medcom will be administered at the study visit
All visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked
PanOptix subjects will have been implanted with the toric and non-toric models
Synergy subjects will have been implanted with the toric and non-toric models
Demographic data will be collected to match the groups as closely as possible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None