Stability of Secondary Intraocular Lenses With no Capsular Support

Not Applicable

• Conditions: Cataract

• Registration Number: NCT06345846
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

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.

Study Timeline

• Study Start: 2022-12-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 82

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Centration of the IOL	24 months	Centration of the IOL will be measured in mm using a Purkinjemeter

Secondary Outcome Measures

Name	Time	Method
Tilt of the IOL	24 months	Tilt of the IOL will be measured in degrees using a Purkinjemeter

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna; 🇦🇹 Vienna, Austria