Stability of Secondary Intraocular Lenses With no Capsular Support

NCT ID: NCT06345846

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-30
• Study Completion Date: 2025-12-31

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.

Conditions

Cataract

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

IFIOL

Patients with an implanted IFIOL

Group Type: EXPERIMENTAL

IFIOL

Intervention Type: DEVICE

Implanted IFIOL

SFIOL

Patients with an implanted SFIOL

Group Type: EXPERIMENTAL

SFIOL

Intervention Type: DEVICE

Implanted SFIOL

Interventions

IFIOL

Implanted IFIOL

Intervention Type: DEVICE

SFIOL

Implanted SFIOL

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Findl, Prim. Dr.

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus

Locations

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

Secondary IOL

Identifier Type: -

Identifier Source: org_study_id