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Stability of Secondary Intraocular Lenses With no Capsular Support

Tilt, Centration and Stability of Secondary Intraocular Lenses With no Capsular Support

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06345846
Enrollment
82
Registered
2024-04-03
Start date
2022-12-30
Completion date
2025-12-31
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Secondary IOL, Stability

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.

Interventions

DEVICEIFIOL

Implanted IFIOL

DEVICESFIOL

Implanted SFIOL

Sponsors

Vienna Institute for Research in Ocular Surgery
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Centration of the IOL24 monthsCentration of the IOL will be measured in mm using a Purkinjemeter

Secondary

MeasureTime frameDescription
Tilt of the IOL24 monthsTilt of the IOL will be measured in degrees using a Purkinjemeter

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026