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Natural History of IOL in Pseudo Exfoliation Syndrome (PXF)

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. Identifier: NCT01255995
Recruitment Status : Active, not recruiting
First Posted : December 8, 2010
Last Update Posted : November 16, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Pseudo Exfoliation Syndrome Device: Capsular Tension Ring

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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome
Study Start Date : December 2010
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Control Patients
Controls without PXF who require cataract surgery
Pseudo Exfoliation patients
PXF subjects with or without glaucoma who require cataract surgery
Device: Capsular Tension Ring
Capsular Tension Ring
Other Name: CTR

Primary Outcome Measures :
  1. IOL Centration / IOL Stability [ Time Frame: 10th Year ]

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 10th Year ]
  2. Anterior capsular fibrosis/phimosis [ Time Frame: 10th Year ]
  3. New onset of phacodonesis [ Time Frame: 10th Year ]
  4. Development or worsening of glaucoma [ Time Frame: 10th Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
PXF subjects with or without glaucoma who require cataract surgery. Controls without PXF who require cataract surgery

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255995

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Aravind Eye Hospital
Coimbatore, Tamil Nadu, India, 641014
Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625020
Aravind Eye Hospital
Pondicherry, Tamil Nadu, India, 605 007
Aravind Eye Hospital
Tirunelveli, Tamil Nadu, India, 627001
Sponsors and Collaborators
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Principal Investigator: Haripriya Aravind, MS Aravind Eye Hospital

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Responsible Party: Aurolab Identifier: NCT01255995     History of Changes
Other Study ID Numbers: 2PR2240936
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: November 16, 2012
Last Verified: November 2012
Keywords provided by Aurolab:
Additional relevant MeSH terms:
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Exfoliation Syndrome
Pathologic Processes
Iris Diseases
Uveal Diseases
Eye Diseases