Overview

This trial is active, not recruiting.

Condition pseudo exfoliation syndrome
Treatment capsular tension ring
Sponsor Aurolab
Start date December 2010
End date December 2021
Trial size 1500 participants
Trial identifier NCT01255995, 2PR2240936

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Controls without PXF who require cataract surgery
PXF subjects with or without glaucoma who require cataract surgery
capsular tension ring CTR
Capsular Tension Ring

Primary Outcomes

Measure
IOL Centration / IOL Stability
time frame: 10th Year

Secondary Outcomes

Measure
Visual Acuity
time frame: 10th Year
Anterior capsular fibrosis/phimosis
time frame: 10th Year
New onset of phacodonesis
time frame: 10th Year
Development or worsening of glaucoma
time frame: 10th Year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome
Principal investigator Haripriya Aravind, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Aurolab.