Clinical trial NCT06345846: Stability of Secondary Intraocular Lenses With no Capsular Support
Official title: Tilt, Centration and Stability of Secondary Intraocular Lenses With no Capsular Support
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cataract
Keywords: Secondary IOL
Stability
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 82
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: Inclusion Criteria:

* Secondary IOL implantation performed at the Hanusch Hospital
* IFIOL or SFIOL implanted
* Older than 21 years
* Written informed consent prior to recruitment

Exclusion Criteria:

* Concurrent participation in another drug or device clinical investigation
* Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)

Primary outcomes:
measure: Centration of the IOL
timeFrame: 24 months
Secondary outcomes:
measure: Tilt of the IOL
timeFrame: 24 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus
name: Oliver Findl, Prim. Dr.
role: PRINCIPAL_INVESTIGATOR
References: