Natural History of IOL in Pseudo Exfoliation Syndrome (PXF)

Aurolab

Status

Unknown

Conditions

Pseudo Exfoliation Syndrome

Treatments

Device: Capsular Tension Ring

Study type

Observational

Funder types

Other

Identifiers

NCT01255995

2PR2240936

Details and patient eligibility

About

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

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 40-75
PXF with or without secondary open-angle glaucoma who present with cataract and willing to undergo phacoemulsification with IOL
Nuclear sclerosis with LOCS III grade and above
Pupil size more than 4mm on dilatation
Endothelial cell count >1,500
No visible phacodonesis

Exclusion criteria