Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345846
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-03
First Post:
2024-03-28
Brief Title:
Stability of Secondary Intraocular Lenses With no Capsular Support
Sponsor:
Vienna Institute for Research in Ocular Surgery
Organization:
Vienna Institute for Research in Ocular Surgery
Study Overview
Official Title:
Tilt Centration and Stability of Secondary Intraocular Lenses With no Capsular Support
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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:
Assessment and differences in the centration tilt and wobble of two secondary IOLs without capsular support
Detailed Description:
Acquired or congenital weakness of the zonules either as part of a pseudoexfoliation syndrome PEX high myopia past ocular trauma post vitreoretinal surgery and recurrent uveitis are the most common reasons for implantation of a secondary intraocular lenses IOL after cataract surgery There are several techniques available to implant a secondary IOL in eyes with inadequate capsular support Some of the most common techniques are the placement of a chamber angle-supported anterior chamber IOL ACIOL an iris-fixated IOL IFIOL and several different possibilities of scleral fixation of the IOL SFIOL
While those methods have all been found to show high safety and efficiency there are certain procedure-specific limitations One approach to sutureless implantation of a SFIOL is the double needle flanged technique described by Yamane et al When using this technique there is no need for extensive scleral incisions or distinct scleral manipulation however it may be challenging for the surgeon and may lead to complications such as iris-optic-capture
Past studies found no significant difference of postoperative best corrected visual acuity or rate of complications when comparing the three mentioned techniques therefore up to now choice of implantation and fixation technique lies with the surgeons preferences and abilities However all three techniques have their drawbacks
Hence the aim of this study is to assess the centration tilt and wobble of secondary IOLs comparing an IFIOL and a SFIOL without capsular support
While those methods have all been found to show high safety and efficiency there are certain procedure-specific limitations One approach to sutureless implantation of a SFIOL is the double needle flanged technique described by Yamane et al When using this technique there is no need for extensive scleral incisions or distinct scleral manipulation however it may be challenging for the surgeon and may lead to complications such as iris-optic-capture
Past studies found no significant difference of postoperative best corrected visual acuity or rate of complications when comparing the three mentioned techniques therefore up to now choice of implantation and fixation technique lies with the surgeons preferences and abilities However all three techniques have their drawbacks
Hence the aim of this study is to assess the centration tilt and wobble of secondary IOLs comparing an IFIOL and a SFIOL without capsular support
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None