Performance of Two Sclera Fixated Intraocular Lens Concepts
NCT ID: NCT05779306
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2023-01-19
2024-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Carlevale
Patients who had a Carlevale lens implanted
IOL Master 700
Biometry using the IOL Master 700
Casia-2
Anterior segment-OCT to evaluate lens tilt
MS-39
Corneal Topography using the MS-39
OSIRIS
Abberometry using the OSIRIS-Abberometer
Autorefractor
Evaluation of Refraction using an Autorefractor
Subjective Refraction
Refraction performed by experienced staff
Yamane
Patients who had a lens implanted using Yamane technique
IOL Master 700
Biometry using the IOL Master 700
Casia-2
Anterior segment-OCT to evaluate lens tilt
MS-39
Corneal Topography using the MS-39
OSIRIS
Abberometry using the OSIRIS-Abberometer
Autorefractor
Evaluation of Refraction using an Autorefractor
Subjective Refraction
Refraction performed by experienced staff
Interventions
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IOL Master 700
Biometry using the IOL Master 700
Casia-2
Anterior segment-OCT to evaluate lens tilt
MS-39
Corneal Topography using the MS-39
OSIRIS
Abberometry using the OSIRIS-Abberometer
Autorefractor
Evaluation of Refraction using an Autorefractor
Subjective Refraction
Refraction performed by experienced staff
Eligibility Criteria
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Inclusion Criteria
* planned surgery or already taken place surgery using a scleral fixated lens
Exclusion Criteria
* pregnancy
* missing informed consent form
21 Years
110 Years
ALL
No
Sponsors
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Johannes Kepler University of Linz
OTHER
Responsible Party
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Principal Investigators
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Nino Hirnschall, MD
Role: PRINCIPAL_INVESTIGATOR
Johannes Kepler University
Locations
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Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
Linz, Upper Austria, Austria
Countries
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Other Identifiers
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KUK-Ophthalmology-011
Identifier Type: -
Identifier Source: org_study_id
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