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Stability of Secondary Intraocular Lenses With no Capsular Support

V

Vienna Institute for Research in Ocular Surgery

Status

Invitation-only

Conditions

Cataract

Treatments

Device: SFIOL
Device: IFIOL

Study type

Interventional

Funder types

Other

Identifiers

NCT06345846
Secondary IOL

Details and patient eligibility

About

Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support.

Full 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.

Enrollment

82 estimated patients

Sex

All

Ages

21 to 100 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

IFIOL
Experimental group
Description:
Patients with an implanted IFIOL
Treatment:
Device: IFIOL
SFIOL
Experimental group
Description:
Patients with an implanted SFIOL
Treatment:
Device: SFIOL

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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