Stability of Secondary Intraocular Lenses With no Capsular Support

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06345846
• Other study ID #: Secondary IOL
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Cataract

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