Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624826
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Visual Performance of an Extended Depth of Focus IOL in an Emmetropic or Monovision Modality
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Difference in Visual Performance of a Refractive Extended Depth of Focus Intraocular Lens in an Emmetropic or Monovision Modality
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality
Detailed Description:
With an expanding market of different types of intraocular lenses IOL spectacle independence is a rising aim in modern cataract surgery The procedure has in many cases changed from a vision restoring to a presbyopia correcting approach Although bilateral monofocal IOL implantation aiming for emmetropia leads to high levels of patient satisfaction for distance vision spectacle dependence for reading and intermediate vision tasks is the usual result
The option commonly used to achieve spectacle independence at intermediate distance eg PC work is the implantation of enhanced depth of focus EDOF IOLs These IOLs have an extended far focus area which reaches to the intermediate distance providing high-quality vision over a continuous range of focus rather than distinct foci with blur in between In the last years several technologies for EDOF IOLs appeared on the market The spectrum ranges from small aperture design bioanalogic design to diffractive and non-diffractive optics The disadvantage compared to monofocal lenses in all the technologies mentioned is the potentially worse distance vision and contrast sensitivity as well as dysphotopsia
A new refractive EDOF lens segment with an extended depth of vision was introduced which promises an increased range of functional vision and less dysphotopsias compared to diffractive EDOF lenses These non-diffractive IOLs are believed to be a presbyopia correcting alternative for people with existing corneal or macula pathologies which would preclude them from receiving premium lenses because of the loss of light in the diffractive process To increase spectacle independence for these patients IOLs may be used in a monovision modality with an offset of up to 15dpt This method showed good results in the literature so far for monofocal and multifocal intraocular lenses
Aim of the study is to compare a new non-diffractive EDOF-IOL namely the PureSee set for emmetropia or monovision
120 eyes of 60 patients will be included into this study Patients will be either randomized in the emmetropia or the monovision group
Follow-up visits will be 1 week after each surgery and 3 months post-surgically During these visits the clinical variables to be assessed will be visual acuity stereopsis contrast sensitivity and binocular defocus curves
The option commonly used to achieve spectacle independence at intermediate distance eg PC work is the implantation of enhanced depth of focus EDOF IOLs These IOLs have an extended far focus area which reaches to the intermediate distance providing high-quality vision over a continuous range of focus rather than distinct foci with blur in between In the last years several technologies for EDOF IOLs appeared on the market The spectrum ranges from small aperture design bioanalogic design to diffractive and non-diffractive optics The disadvantage compared to monofocal lenses in all the technologies mentioned is the potentially worse distance vision and contrast sensitivity as well as dysphotopsia
A new refractive EDOF lens segment with an extended depth of vision was introduced which promises an increased range of functional vision and less dysphotopsias compared to diffractive EDOF lenses These non-diffractive IOLs are believed to be a presbyopia correcting alternative for people with existing corneal or macula pathologies which would preclude them from receiving premium lenses because of the loss of light in the diffractive process To increase spectacle independence for these patients IOLs may be used in a monovision modality with an offset of up to 15dpt This method showed good results in the literature so far for monofocal and multifocal intraocular lenses
Aim of the study is to compare a new non-diffractive EDOF-IOL namely the PureSee set for emmetropia or monovision
120 eyes of 60 patients will be included into this study Patients will be either randomized in the emmetropia or the monovision group
Follow-up visits will be 1 week after each surgery and 3 months post-surgically During these visits the clinical variables to be assessed will be visual acuity stereopsis contrast sensitivity and binocular defocus curves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None