Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428363
Status:
COMPLETED
Last Update Posted:
2007-01-30
First Post:
2007-01-29
Brief Title:
Effect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-01
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:
Purpose To compare the posterior capsule opacification PCO inhibiting effect of the sharp posterior optic edge design of the Clariflex silicone intraocular lens IOL with that of the double-round edge design of the SI40 Phacoflex silicone IOL over a period of 3 years
Setting Department of Ophthalmology Medical University of Vienna Vienna Austria
Methods Fifty-two patients with bilateral age-related cataract 104 eyes were included in this randomized prospective bilateral patient- and examiner-masked clinical trial with intra-individual comparison Each study patient had cataract surgery in both eyes and received an SI40 IOL anterior and posterior round optic edges in one eye and a Clariflex IOL with OptiEdge round anterior and sharp posterior optic edge in the other eye Follow-up examinations were at one week one month six months one two and three years Digital retroillumination images were taken of each eye The amount of PCO was assessed subjectively at the slit-lamp and objectively using automated image analysis software AQUA one two and three years after surgery
Setting Department of Ophthalmology Medical University of Vienna Vienna Austria
Methods Fifty-two patients with bilateral age-related cataract 104 eyes were included in this randomized prospective bilateral patient- and examiner-masked clinical trial with intra-individual comparison Each study patient had cataract surgery in both eyes and received an SI40 IOL anterior and posterior round optic edges in one eye and a Clariflex IOL with OptiEdge round anterior and sharp posterior optic edge in the other eye Follow-up examinations were at one week one month six months one two and three years Digital retroillumination images were taken of each eye The amount of PCO was assessed subjectively at the slit-lamp and objectively using automated image analysis software AQUA one two and three years after surgery
Detailed Description:
None
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