Trials / Unknown
UnknownNCT06345846
Stability of Secondary Intraocular Lenses With no Capsular Support
Tilt, Centration and Stability of Secondary Intraocular Lenses With no Capsular Support
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- Sponsor
- Vienna Institute for Research in Ocular Surgery · Academic / Other
- Sex
- All
- Age
- 21 Years – 100 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IFIOL | Implanted IFIOL |
| DEVICE | SFIOL | Implanted SFIOL |
Timeline
- Start date
- 2022-12-30
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2024-04-03
- Last updated
- 2024-04-03
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT06345846. Inclusion in this directory is not an endorsement.