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Natural History of IOL in Pseudo Exfoliation Syndrome (PXF)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255995
First Posted: December 8, 2010
Last Update Posted: November 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aurolab
December 2, 2010
December 8, 2010
November 16, 2012
December 2010
December 2021   (Final data collection date for primary outcome measure)
IOL Centration / IOL Stability [ Time Frame: 10th Year ]
Same as current
Complete list of historical versions of study NCT01255995 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Natural History of IOL in Pseudo Exfoliation Syndrome
The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome
  • 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
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
PXF subjects with or without glaucoma who require cataract surgery. Controls without PXF who require cataract surgery
Pseudo Exfoliation Syndrome
Device: Capsular Tension Ring
Capsular Tension Ring
Other Name: CTR
  • Control Patients
    Controls without PXF who require cataract surgery
  • Pseudo Exfoliation patients
    PXF subjects with or without glaucoma who require cataract surgery
    Intervention: Device: Capsular Tension Ring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1500
May 2022
December 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01255995
2PR2240936
Yes
Not Provided
Not Provided
Aurolab
Aurolab
Not Provided
Principal Investigator: Haripriya Aravind, MS Aravind Eye Hospital
Aurolab
November 2012