Performance of Two Sclera Fixated Intraocular Lens Concepts (Carlevale)

To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy).

Study Overview

• Status: Completed
• Conditions: Cataract Complicated; Cataract Complications Operations
• Intervention / Treatment: Device: IOL Master 700; Device: Casia-2; Device: MS-39; Device: OSIRIS; Device: Autorefractor; Diagnostic test: Subjective Refraction

Detailed Description

Various approaches to fix the haptics in the sclera can be found in literature. A distinction can be made between suture-fixed and sutureless techniques. The former often proves to be technically challenging and complicated, which has led to an increased rethinking towards sutureless implantation in recent years.

The popular Yamane technique or "flanged IOL fixation" uses a double-needle technique that creates a scleral tunnel and fixates the haptics seamlessly using two 30-gauge needles. However, the haptics must be bent for this purpose Thus, this method is not ideal, since besides from the high degree of manipulation necessary for implantation of the IOL, it is also prone to dislocation and tilt.

A more recent approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with a lack of capsular stability. Using two t-shaped anchors, the lens is positioned in two scleral flaps at 180 degrees to each other, without the preparation of a tunnel or excessive manipulation of the haptics. These two self-blocking anchors also provide a great deal of stability. The extent of abberations is also much less with this type of lens implantation, as the fixed position reduces the risk of them. Thus, the Carlevale technique represents a new, potentially superior option for intrascleral fixation.

However, all these types of implantation are not free from aberrations, tilt, or even dislocation. Many factors influence the outcome of IOL implantation, the optimal choice of intraocular lens power, the surgeon's experience regarding fixation in more challenging eyes, or individual anatomical conditions. As part of quality management, an evaluation of monthly and six-monthly data will be performed. The aim of this study is the evaluation of the postoperative tilt of the Carlevale lens, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management. Patients who have already undergone surgery are called to our clinic by telephone at the earliest 6 weeks after surgery for a one-time follow-up appointment.

The collected data is then evaluated and analyzed as well as compared to the Yamane data.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4020
      • Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients recruited all underwent ocular surgery with implantation of a scleral fixated lens, either using the Carlevale lens or the Yamane technique

Description

Inclusion Criteria:

• minimum age of 21 years
• planned surgery or already taken place surgery using a scleral fixated lens

Exclusion Criteria:

• best corrected visual acuity <0.05 Snellen
• pregnancy
• missing informed consent form

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carlevale; Patients who had a Carlevale lens implanted	Device: IOL Master 700; Biometry using the IOL Master 700; Device: Casia-2; Anterior segment-OCT to evaluate lens tilt; Device: MS-39; Corneal Topography using the MS-39; Device: OSIRIS; Abberometry using the OSIRIS-Abberometer; Device: Autorefractor; Evaluation of Refraction using an Autorefractor; Diagnostic test: Subjective Refraction; Refraction performed by experienced staff
Yamane; Patients who had a lens implanted using Yamane technique	Device: IOL Master 700; Biometry using the IOL Master 700; Device: Casia-2; Anterior segment-OCT to evaluate lens tilt; Device: MS-39; Corneal Topography using the MS-39; Device: OSIRIS; Abberometry using the OSIRIS-Abberometer; Device: Autorefractor; Evaluation of Refraction using an Autorefractor; Diagnostic test: Subjective Refraction; Refraction performed by experienced staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tilt	Postoperative Tilt	6 Weeks
Autorefraction	Refraction using an automated refractor	6 Weeks
Subjective Refraction	Refraction performed by experienced staff	6 Weeks
Best corrected visual acuity	Measurement performed by experienced staff	6 Weeks
uncorrected visual acuity	Measurement performed by experienced staff	6 Weeks

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz
• Investigators: Principal Investigator: Nino Hirnschall, MD, Johannes Kepler University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: KUK-Ophthalmology-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes