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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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 82
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years to 100 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
IFIOL
Implanted IFIOL
SFIOL
Implanted SFIOL

Locations

Country Name City State
Austria Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Centration of the IOL Centration of the IOL will be measured in mm using a Purkinjemeter 24 months
Secondary Tilt of the IOL Tilt of the IOL will be measured in degrees using a Purkinjemeter 24 months
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