Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-28 @ 9:35 PM
Study NCT ID:
NCT01255995
Status:
UNKNOWN
Last Update Posted:
2012-11-16
First Post:
2010-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History of IOL in Pseudo Exfoliation Syndrome
Sponsor:
Aurolab
Organization:
Study Overview
Official Title:
The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome
Status:
UNKNOWN
Status Verified Date:
2012-11
Last Known Status:
ACTIVE_NOT_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:
PXF
Brief Summary:
* The purpose of this study is to determine the natural course of IOL in PXF,
* To demonstrate use of a clinical grading system for PXF,
* To strategize a way to prevent IOL dislocation, subluxation post operatively,
* To demonstrate intraoperative and long-term post-operative complications associated with phaco and PXF
* To suggest evidence-based ways to minimize these complications, by using capsular tension rings (CTR), specific IOL material or size
* To demonstrate use of a clinical grading system for PXF,
* To strategize a way to prevent IOL dislocation, subluxation post operatively,
* To demonstrate intraoperative and long-term post-operative complications associated with phaco and PXF
* To suggest evidence-based ways to minimize these complications, by using capsular tension rings (CTR), specific IOL material or size
Detailed Description:
Pseudo exfoliation syndrome (PXF) is a generalized degenerative microfibrillopathy that primarily is manifested with deposits of exfoliative material present on the anterior capsule of the crystalline lens, zonules, papillary margin of the iris, corneal endothelium, ciliary body and the trabecular meshwork. The build of this exfoliative material causes microscopic changes of the zonules and their attachments, causing a weakening of the zonules. These clinical findings have implications not only for cataract surgery, as association of lens opacities with exfoliation syndrome is well documented but also for glaucoma, with exfoliative glaucoma being the most common cause for secondary open angle glaucoma in the world.In patients with exfoliation syndrome, small pupil and phacodonesis, comparison between extra capsular cataract extraction and small incision cataract surgery revealed better best corrected visual acuity and fewer intra and post operative complications with the smaller incision for phacoemulsification. The capsular tension rings (CTR) implanted prior to phacoemulsification reduced intraoperative zonular dialysis, increased the rate of capsular IOL fixation, and improved uncorrected visual acuity. Either the degree of lens change the stage of PXF, or the type of IOL might influence long term outcome in PXF associated with cataract surgery:The postoperative course of those with either more advanced cataract or with more advanced PXF may be different than those who have surgery with less cataract our and/or degree of PXF. The stage of PXF alone at the time of cataract surgery may influence outcome. Once PXF identified, surgery performed at an earlier stage of cataract with a softer lens in XFS results in fewer long term problems following phacoemulsification. A standardized way of clinically measuring/monitoring XFS is helpful during large clinical studies Specific intraocular lens design should be considered when scheduling phacoemulsification in patients with PXF.
Study Oversight
Has Oversight DMC:
True
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?: