Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00348270
Status:
COMPLETED
Last Update Posted:
2010-05-12
First Post:
2006-07-03
Brief Title:
Comparison of the Quality of Vision Provided by AMO Tecnis Z9000 and Alcon Laboratories MA60 Acrysof Posterior Chamber Intraocular Lenses
Sponsor:
Singapore National Eye Centre
Organization:
Singapore National Eye Centre
Study Overview
Official Title:
Comparison of the Quality of Vision Provided by AMO Tecnis Z9000 Three-piece Silicone Posterior Chamber Intraocular Lens and Alcon Laboratories MA60 Acrysof Three-piece Acrylic Posterior Chamber Intraocular Lens
Status:
COMPLETED
Status Verified Date:
2010-05
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:
None
Brief Summary:
This study is a comparison of the quality of vision provided by AMO Tecnis Z9000 three-piece silicone posterior chamber intraocular lens and Alcon Laboratories MA60 three-piece acrylic posterior chamber intraocular lens
Detailed Description:
Today intraocular lenses IOLs are routinely implanted after cataract extraction Cataract surgical techniques are constantly developing due to innovations in surgical implantation and IOL manufacturing processes Although material development and surgical implantation have advanced extensively during the past several years there has been little attention paid to the improvement of the optical quality of IOLs
It has been documented that the vision of an IOL patient is no better than that of a person with healthy eyes of a similar age ie when a 65-year-old patient with cataracts has them removed and implanted with an IOL the resulting visual outcome is no better than the visual quality of a 65-year-old without cataracts The fact that the visual quality of the IOL patients is no better than that of their same-age counterparts is surprising because an IOL is optically superior to the natural crystalline lens This fact may be explained by aberrations
Aberrations cause incoming light that would otherwise be focused to a point to be blurred which in turn causes a reduction in visual quality This reduction in quality is more severe under low luminance conditions because ocular aberrations increase when the pupil size gets larger The Z9000 is an IOL that is designed to counteract the spherical aberration of the cornea and thus improve the resulting visual quality of IOL patients
Different materials and lens designs result in different visual quality The handling of the lens proper centration in the eye the postoperative course and the optical image may vary depending on the design of the lens Two lenses will be compared AMO Tecnis Z9000 three-piece silicone lens and Alcon Laboratories MA60 three-piece acrylic lens
This will be a randomized evaluator-masked study in bilateral cataract surgery patients Each patient will be assigned to a AMO Tecnis Z9000 lens in one eye and an Alcon Laboratories MA60 lens in the other eye All first surgeries will be on the right eye A randomization list will be used to decide lens allocation
A total of 80 patients men and women from the Singapore National Eye Centre will be enrolled in the study All patients will undergo wavefront analysis 90-120 days postoperatively
The two lens models look different even in the eye after implantation It is not possible to mask the individual investigator at the time of surgery or personnel responsible for conducting the clinical ocular examinations eg evaluation of complications posterior capsule IOP pupil size and optic evaluations eg evaluation of the IOL
It has been documented that the vision of an IOL patient is no better than that of a person with healthy eyes of a similar age ie when a 65-year-old patient with cataracts has them removed and implanted with an IOL the resulting visual outcome is no better than the visual quality of a 65-year-old without cataracts The fact that the visual quality of the IOL patients is no better than that of their same-age counterparts is surprising because an IOL is optically superior to the natural crystalline lens This fact may be explained by aberrations
Aberrations cause incoming light that would otherwise be focused to a point to be blurred which in turn causes a reduction in visual quality This reduction in quality is more severe under low luminance conditions because ocular aberrations increase when the pupil size gets larger The Z9000 is an IOL that is designed to counteract the spherical aberration of the cornea and thus improve the resulting visual quality of IOL patients
Different materials and lens designs result in different visual quality The handling of the lens proper centration in the eye the postoperative course and the optical image may vary depending on the design of the lens Two lenses will be compared AMO Tecnis Z9000 three-piece silicone lens and Alcon Laboratories MA60 three-piece acrylic lens
This will be a randomized evaluator-masked study in bilateral cataract surgery patients Each patient will be assigned to a AMO Tecnis Z9000 lens in one eye and an Alcon Laboratories MA60 lens in the other eye All first surgeries will be on the right eye A randomization list will be used to decide lens allocation
A total of 80 patients men and women from the Singapore National Eye Centre will be enrolled in the study All patients will undergo wavefront analysis 90-120 days postoperatively
The two lens models look different even in the eye after implantation It is not possible to mask the individual investigator at the time of surgery or personnel responsible for conducting the clinical ocular examinations eg evaluation of complications posterior capsule IOP pupil size and optic evaluations eg evaluation of the IOL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None