Stability of Secondary Intraocular Lenses With no Capsular Support

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cataract
• Intervention / Treatment: Device: IFIOL; Device: SFIOL

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 Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IFIOL; Patients with an implanted IFIOL	Device: IFIOL; Implanted IFIOL
Experimental: SFIOL; Patients with an implanted SFIOL	Device: SFIOL; Implanted SFIOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Centration of the IOL	Centration of the IOL will be measured in mm using a Purkinjemeter	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tilt of the IOL	Tilt of the IOL will be measured in degrees using a Purkinjemeter	24 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery
• Investigators: Principal Investigator: Oliver Findl, Prim. Dr., Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Stability; Secondary IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Secondary IOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No