Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607848
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia
Detailed Description:
Spectacle-independence is a growing goal in modern cataract surgery The procedure has evolved from a simple restoration of vision to a presbyopia correction approach Although bilateral monofocal IOL implantation with the goal of emmetropia results in high patient satisfaction for distance vision spectacle-dependence for reading and intermediate vision tasks is the usual outcome
Enhanced Depth of Focus EDOF lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks computer work dashboard etc These IOLs have an extended distance focal range that extends into the intermediate distance providing high quality vision over a continuous focal range rather than single foci with blurring in between The risk to the patient is comparable to that of all other monofocal systems which generally have high patient satisfaction The benefit of this study should be continuous sharp binocular vision at distance intermediate 66 cm and even near 40 cm Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses
The aim of this study is to compare the visual performance of two refractive EDOF lenses namely the Acunex Vario with the Puresee IOL in an intraindividual comparative study design In order to achieve a satisfactory result we planned to include 40 patients scheduled for cataract surgery in the study
The examinations will all take place one week before 1 week and 4-6 months after the operation These include a visual acuity check at the three distances mentioned slit lamp examination pressure control biometry pupil width defocus curve quality of vision questionnaires contrast sensitivity haloampglare optical coherence tomography fundus examination aberrometry and keratometry
The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance 66 cm between the two IOLs at the follow-up examination after 4-6 months
Enhanced Depth of Focus EDOF lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks computer work dashboard etc These IOLs have an extended distance focal range that extends into the intermediate distance providing high quality vision over a continuous focal range rather than single foci with blurring in between The risk to the patient is comparable to that of all other monofocal systems which generally have high patient satisfaction The benefit of this study should be continuous sharp binocular vision at distance intermediate 66 cm and even near 40 cm Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses
The aim of this study is to compare the visual performance of two refractive EDOF lenses namely the Acunex Vario with the Puresee IOL in an intraindividual comparative study design In order to achieve a satisfactory result we planned to include 40 patients scheduled for cataract surgery in the study
The examinations will all take place one week before 1 week and 4-6 months after the operation These include a visual acuity check at the three distances mentioned slit lamp examination pressure control biometry pupil width defocus curve quality of vision questionnaires contrast sensitivity haloampglare optical coherence tomography fundus examination aberrometry and keratometry
The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance 66 cm between the two IOLs at the follow-up examination after 4-6 months
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