Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06345846 |
Other study ID # |
Secondary IOL |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 30, 2022 |
Est. completion date |
December 2025 |
Study information
Verified date |
March 2024 |
Source |
Vienna Institute for Research in Ocular Surgery |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Assessment and differences in the centration, tilt and wobble of two secondary IOLs without
capsular support.
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 surgeon's 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.