Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05779306
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2023-03-09
Brief Title:
Performance of Two Sclera Fixated Intraocular Lens Concepts
Sponsor:
Johannes Kepler University of Linz
Organization:
Johannes Kepler University of Linz
Study Overview
Official Title:
Performance of Two Sclera Fixated Intraocular Lens Concepts
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Carlevale
Brief Summary:
To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts the Yamane method ZA9003 JJ USA and the Carlevale IOL FIL-SSF Soleko Italy
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 surgeons 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
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 surgeons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None