Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04570579
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2020-09-13
Brief Title:
Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement
Sponsor:
Alanna Nattis DO
Organization:
Sight Medical Doctors PLLC
Study Overview
Official Title:
Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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 introduction of presbyopia-correcting intraocular lenses PC-IOLs has provided cataract and refractive surgeons the ability to provide patients with a wider range of visual success and spectacle independence post-cataract surgeryMultifocal MFIOL IOLs have the ability to provide near and distance vision and in the case of trifocal IOLs near intermediate and distance Despite the significant technological evolution of MFIOLs the potential for visual disturbances such as glare halos and starbursts still exists-and in much greater frequency compared to their monofocal counterparts
Extended depth of focus EDOF IOLs aim to provide patients with a functional range of vision with a similar visual disturbance profile to a monofocal lens In this way this subset of PC-IOLs can offer patients some degree of spectacle independence with a significantly lower incidence of visual disturbances
The Vivity Extended Vision IOL is the first of its kind to offer Wavefront Stretching technology providing patients with an excellent extended range of vision from intermediate to distance as well as some functional near vision Prior studies have demonstrated very good vision in both bright and dim lighting conditions as well as a high degree of spectacle independence with the Vivity IOL as compared to a monofocal IOL
Studies evaluating the ability of the Vivity IOL to provide a significant impact on patient lifestyle eg patient independence from spectacles for most activities with a low rate of visual disturbances in the United States in a real-world setting have yet to be performed In addition influence of pre-and-perioperative variables such as sex age prior refractive surgery IOL formula used axial length astigmatism use of intraoperative aberrometry femtosecond laser and pupillary expansion devices has yet to be evaluated on the postoperative success of this IOL
This study will be comprised of patients with visually significant cataracts who will undergo cataract extraction with implantation of the spherical andor toric models of the Vivity Extended Vision Alcon Fort Worth TX intraocular lens Upon decision of the patient and surgeon to undergo surgery patients will be offered the option to enroll in this observational study
Extended depth of focus EDOF IOLs aim to provide patients with a functional range of vision with a similar visual disturbance profile to a monofocal lens In this way this subset of PC-IOLs can offer patients some degree of spectacle independence with a significantly lower incidence of visual disturbances
The Vivity Extended Vision IOL is the first of its kind to offer Wavefront Stretching technology providing patients with an excellent extended range of vision from intermediate to distance as well as some functional near vision Prior studies have demonstrated very good vision in both bright and dim lighting conditions as well as a high degree of spectacle independence with the Vivity IOL as compared to a monofocal IOL
Studies evaluating the ability of the Vivity IOL to provide a significant impact on patient lifestyle eg patient independence from spectacles for most activities with a low rate of visual disturbances in the United States in a real-world setting have yet to be performed In addition influence of pre-and-perioperative variables such as sex age prior refractive surgery IOL formula used axial length astigmatism use of intraoperative aberrometry femtosecond laser and pupillary expansion devices has yet to be evaluated on the postoperative success of this IOL
This study will be comprised of patients with visually significant cataracts who will undergo cataract extraction with implantation of the spherical andor toric models of the Vivity Extended Vision Alcon Fort Worth TX intraocular lens Upon decision of the patient and surgeon to undergo surgery patients will be offered the option to enroll in this observational study
Detailed Description:
Presbyopia-correcting intraocular lenses PC-IOLs provide cataract and refractive surgeons with an effective treatment option for presbyopia allowing patients increased spectacle independence post-cataract surgery Different IOL designs have been developed based on differing optical principals such as diffractive refractive and extended depth of focus EDOF design Most commercially available MFIOLs have two optical zones one that provides distance vision and the second that provides near vision ie bifocal IOLs Most recently trifocal IOLs have been released with the aim of providing a third intermediate focal point and hence an extended range of vision in pseudophakic patients While being able to provide patients with near intermediate and distance vision most MFIOLs carry the risk of increased visual disturbances such as glare starbursts and halos which for a small percentage of patients may become quite bothersome or even debilitating
Extended depth of focus EDOF IOLs aim to provide an extended range of vision from intermediate to distance with a similar visual disturbance profile to their monofocal counterparts Prior to recent FDA approval there was only one other EDOF IOL on the market in the US which although provides an extended visual range still had a significant incidence of starbursts and visual disturbances in some patients FDA approved in February 2020 the Vivity Extended Vision Lens has demonstrated the ability to provide patients with an extended range of vision excellent contrast sensitivity and visual disturbance profile comparable to a monofocal IOL as well as high rates of spectacle independence for most activities
The Vivity Extended Vision IOL Alcon Laboratories Fort Worth TX is an EDOF IOL made of hydrophobic acrylic This non-diffractive lens was designed to mitigate the effect of presbyopia by providing an extended depth of focus through patented Wavefront Shaping technology In clinical trials Vivity has demonstrated significantly better intermediate and near vision as compared to a monofocal IOL as well as superior spectacle independence scores Additionally a validated questionnaire regarding visual disturbances showed the Vivity to have comparable rates of starburst glare and halos to its monofocal counterpart
In an era where intermediate vision has become very important eg using laptops tablets seeing the dashboard in a car many patients express desire for visual correction at all possible focal points Vivity appears to deliver this with minimal visual side effects-even less so as compared to other MFIOLs This is a valuable aspect of Vivity spectacle independence is an important factor for many patients-however if this is coupled with debilitating glare haloes or other visual disturbances dissatisfaction will ultimately result
Multiple studies have explored variables that may influence postoperative success of these MFIOLs including the impact of dry eye prior corneal refractive surgery and proper preoperative consentexpectations
A study has yet to be performed evaluating not only preoperative factors such as astigmatism and prior corneal refractive surgery but also perioperative and intraoperative factors that may also play a role in success of the Vivity IOL implant In this prospective nonrandomized real-world study the impact of perioperative factors such as IOL formulae used use of femtosecond laser use of intraoperative aberrometry as well use of pupillary expansion devices on surgical success will be evaluated Surgical success will be defined as uncorrected distance intermediate and near visual acuity UDVA UIVA and UNVA respectively of 2040 or better both monocular and binocular as well as high levels of patient satisfaction which will be recorded with a Visual Disturbance Questionnaire Spectacle Independence Questionnaire and Visual Quality Questionnaire
Results will provide never-before-published data on important preoperative as well as perioperative factors that may influence success and patient satisfaction with Vivity IOL implantation
Extended depth of focus EDOF IOLs aim to provide an extended range of vision from intermediate to distance with a similar visual disturbance profile to their monofocal counterparts Prior to recent FDA approval there was only one other EDOF IOL on the market in the US which although provides an extended visual range still had a significant incidence of starbursts and visual disturbances in some patients FDA approved in February 2020 the Vivity Extended Vision Lens has demonstrated the ability to provide patients with an extended range of vision excellent contrast sensitivity and visual disturbance profile comparable to a monofocal IOL as well as high rates of spectacle independence for most activities
The Vivity Extended Vision IOL Alcon Laboratories Fort Worth TX is an EDOF IOL made of hydrophobic acrylic This non-diffractive lens was designed to mitigate the effect of presbyopia by providing an extended depth of focus through patented Wavefront Shaping technology In clinical trials Vivity has demonstrated significantly better intermediate and near vision as compared to a monofocal IOL as well as superior spectacle independence scores Additionally a validated questionnaire regarding visual disturbances showed the Vivity to have comparable rates of starburst glare and halos to its monofocal counterpart
In an era where intermediate vision has become very important eg using laptops tablets seeing the dashboard in a car many patients express desire for visual correction at all possible focal points Vivity appears to deliver this with minimal visual side effects-even less so as compared to other MFIOLs This is a valuable aspect of Vivity spectacle independence is an important factor for many patients-however if this is coupled with debilitating glare haloes or other visual disturbances dissatisfaction will ultimately result
Multiple studies have explored variables that may influence postoperative success of these MFIOLs including the impact of dry eye prior corneal refractive surgery and proper preoperative consentexpectations
A study has yet to be performed evaluating not only preoperative factors such as astigmatism and prior corneal refractive surgery but also perioperative and intraoperative factors that may also play a role in success of the Vivity IOL implant In this prospective nonrandomized real-world study the impact of perioperative factors such as IOL formulae used use of femtosecond laser use of intraoperative aberrometry as well use of pupillary expansion devices on surgical success will be evaluated Surgical success will be defined as uncorrected distance intermediate and near visual acuity UDVA UIVA and UNVA respectively of 2040 or better both monocular and binocular as well as high levels of patient satisfaction which will be recorded with a Visual Disturbance Questionnaire Spectacle Independence Questionnaire and Visual Quality Questionnaire
Results will provide never-before-published data on important preoperative as well as perioperative factors that may influence success and patient satisfaction with Vivity IOL implantation
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?:
False
Is an FDA AA801 Violation?:
None