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OpenTrials
Completed

NCT Number: NCT05779306

Performance of Two Sclera Fixated Intraocular Lens Concepts

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).

Completed

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Key information

Age range

21 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Linz, Upper Austria, 4020, Austria

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IOL Master 700

Device

Biometry using the IOL Master 700

Casia-2

Device

Anterior segment-OCT to evaluate lens tilt

MS-39

Device

Corneal Topography using the MS-39

OSIRIS

Device

Abberometry using the OSIRIS-Abberometer

Autorefractor

Device

Evaluation of Refraction using an Autorefractor

Subjective Refraction

Diagnostic Test

Refraction performed by experienced staff

Primary outcomes

  1. Tilt

    Time frame: 6 Weeks

    Postoperative Tilt

  2. Autorefraction

    Time frame: 6 Weeks

    Refraction using an automated refractor

  3. Subjective Refraction

    Time frame: 6 Weeks

    Refraction performed by experienced staff

  4. Best corrected visual acuity

    Time frame: 6 Weeks

    Measurement performed by experienced staff

  5. uncorrected visual acuity

    Time frame: 6 Weeks

    Measurement performed by experienced staff

Sponsors and collaborators

Lead sponsor

Johannes Kepler University of Linz

Other

Registry information

Acronym: Carlevale

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2023
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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