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Natural History of IOL in Pseudo Exfoliation Syndrome

The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01255995
Acronym
PXF
Enrollment
1500
Registered
2010-12-08
Start date
2010-12-31
Completion date
2022-05-31
Last updated
2012-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudo Exfoliation Syndrome

Keywords

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

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.

Interventions

Capsular Tension Ring

Sponsors

Aurolab
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* Uncontrolled IOP/glaucoma * History of narrow angles, chronic narrow angle glaucoma * Any pre-existing clinical zonular dialysis or phacodonesis * Pseudo uveitis * One eyed patients * Cardiac pathology * Uncontrolled diabetes, hypertension & severe asthma * Obviously debilitated patients * Traumatic cataract * Complicated cataract * Congenital cataract * Drug induced cataract * Shallow anterior Chamber * Amblyopia * Dense posterior polar cataract * Corneal pathology * Retinal pathology * RAPD * Severe visual field defect (MD-\>12.0dB) * Diabetic retinopathy * Combined Surgery

Design outcomes

Primary

MeasureTime frame
IOL Centration / IOL Stability10th Year

Secondary

MeasureTime frame
Visual Acuity10th Year
Anterior capsular fibrosis/phimosis10th Year
New onset of phacodonesis10th Year
Development or worsening of glaucoma10th Year

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026