Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03751215
Status:
UNKNOWN
Last Update Posted:
2019-04-19
First Post:
2018-11-20
Brief Title:
Anterior Chamber Depth Variability Between Two Lenses With Different Materials
Sponsor:
Prim Prof Dr Oliver Findl MBA
Organization:
Vienna Institute for Research in Ocular Surgery
Study Overview
Official Title:
Anterior Chamber Depth ACD Variability Between the Clareon and Acrysof IOL a Randomised Trial
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Compare the change of the Anterior chamber depth ACD variability between the Clareon and the AcrySof Intraocular lens IOL after implantation over 6 months
Detailed Description:
Patients undergoing cataract surgery are often otherwise healthy and active with their only restriction being reduced visual quality Within the past few years intraocular lenses IOLs have been improved to fulfill the needs of these patients Nowadays efforts are aiming for the enhancement of the patient vision and his subjective satisfaction postoperative
One of the best ways to accomplish this is to have a perfect intraocular lens IOL power calculation However the best calculation cant help if the implanted intraocular lens IOL changes its position after implantation
It should be considered that an anterior chamber depth ACD shift decentration tilt or rotation of an IOL could result in a reduction in visual quality For an aspherical IOL for instance it is essential not to be decentrated and tilted more than 04 mm 2 08 mm 3 and 7 2 10 3 respectively Otherwise it will be outperformed by a spherical IOL The estimation of the post-operative intraocular lens IOL position and therefore the estimated anterior chamber depth ACD is presently the main source of error 35 4 to 42 5 in IOL power calculation and therefore for the refractive outcome of the patients after cataract surgery Presently the pre-operatively measured ACD is taken into account for several IOL power calculation formulas such as the Haigis formula the Holladay II formula and the Olsen formula
To manage a better outcome an IOL with less postoperative influence of the anterior chamber depth ACD is very important To accomplish a smaller deviation after the operation of the anterior chamber depth ACD the haptic and the material of the lens is very important The change of the anterior chamber depth ACD after cataract surgery can be easily measured by instruments like the IOL-Master 700 AC-Master and Lenstar It must be considered that every person is different and that change of the anterior chamber depth ACD in different eyes can cause high measurement errors The changes in two eyes of the same patient help to minimize the error These can help to achieve a better outcome for future patients
The hydrophobic acrylate of the Acrysof IOL has been modified to the new material in the Clareon IOL This study will evaluate whether the new Clareon has non-inferior axial stability to the Acrysof
One of the best ways to accomplish this is to have a perfect intraocular lens IOL power calculation However the best calculation cant help if the implanted intraocular lens IOL changes its position after implantation
It should be considered that an anterior chamber depth ACD shift decentration tilt or rotation of an IOL could result in a reduction in visual quality For an aspherical IOL for instance it is essential not to be decentrated and tilted more than 04 mm 2 08 mm 3 and 7 2 10 3 respectively Otherwise it will be outperformed by a spherical IOL The estimation of the post-operative intraocular lens IOL position and therefore the estimated anterior chamber depth ACD is presently the main source of error 35 4 to 42 5 in IOL power calculation and therefore for the refractive outcome of the patients after cataract surgery Presently the pre-operatively measured ACD is taken into account for several IOL power calculation formulas such as the Haigis formula the Holladay II formula and the Olsen formula
To manage a better outcome an IOL with less postoperative influence of the anterior chamber depth ACD is very important To accomplish a smaller deviation after the operation of the anterior chamber depth ACD the haptic and the material of the lens is very important The change of the anterior chamber depth ACD after cataract surgery can be easily measured by instruments like the IOL-Master 700 AC-Master and Lenstar It must be considered that every person is different and that change of the anterior chamber depth ACD in different eyes can cause high measurement errors The changes in two eyes of the same patient help to minimize the error These can help to achieve a better outcome for future patients
The hydrophobic acrylate of the Acrysof IOL has been modified to the new material in the Clareon IOL This study will evaluate whether the new Clareon has non-inferior axial stability to the Acrysof
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None