NCT05912829

Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique

Evaluation of Two Different Intraocular Lens Models After Lens Implantation Using the Yamane Technique

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Johannes Kepler University of Linz · Academic / Other
• Sex: All
• Age: 21 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

In case of instability or rupture of capsular bag occurs during cataract surgery, Yamane technique is one of the options to fix intracocularlens' haptics. Yamane technique uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel. Aberrations, IOL tilting or even dislocations might occur and influence the final outcome of IOL implantation. The aim of this study is the evaluation of the postoperative tilt of Kowa PU6AS using Yamane technique. Furthermore of the corrected and uncorrected visual acuity and the anterior chamber depth are being developed.

Detailed description

During uncomplicated cataract surgery, an intraocular lens (IOL) is implanted into the patient's capsular bag. If increased instability or rupture of this capsular bag occurs due to aggravated intraoperative conditions or IOL dislocation, several options are available to the surgeon to correct the aphakia, all characterized by their respective advantages and disadvantages, but with no clear superiority of any one method. The popular Yamane technique, or "flanged IOL fixation", uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel using two 30-gauge needles. Examples of lenses used for this purpose are the TECNIS ZA9003 (Johnson\&Johnson, USA) and the Kowa PU6AS (Kowa, Japan). Another approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with lack of capsular stability. All types of implantation are not immune to aberrations, tilting or even dislocation. Many factors influence the final outcome of IOL implantation, be it 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 assurance, an evaluation of monthly and six-monthly data will now be performed. The aim of this study is the evaluation of the postoperative tilt of the Kowa PU6AS in Yamane technique, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management.

Conditions

• Secondary Cataract Surgery
• Aphakia
• Complicated Cataract Surgery

Interventions

Type	Name	Description
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
DIAGNOSTIC_TEST	Biomicroscopy	Slit Lamp Examination

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-05-01
• Completion: 2025-05-01
• First posted: 2023-06-22
• Last updated: 2023-10-05

Locations

2 sites across 1 country: Austria