Natural History of IOL in Pseudo Exfoliation Syndrome (PXF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT01255995
First received: December 2, 2010
Last updated: November 15, 2012
Last verified: November 2012
  Purpose
  • 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 Intervention
Pseudo Exfoliation Syndrome
Device: Capsular Tension Ring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome

Resource links provided by NLM:


Further study details as provided by Aurolab:

Primary Outcome Measures:
  • IOL Centration / IOL Stability [ Time Frame: 10th Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 10th Year ] [ Designated as safety issue: No ]
  • Anterior capsular fibrosis/phimosis [ Time Frame: 10th Year ] [ Designated as safety issue: No ]
  • New onset of phacodonesis [ Time Frame: 10th Year ] [ Designated as safety issue: Yes ]
  • Development or worsening of glaucoma [ Time Frame: 10th Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: December 2010
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255995

Locations
India
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
Aurolab
Investigators
Principal Investigator: Haripriya Aravind, MS Aravind Eye Hospital
  More Information

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01255995     History of Changes
Other Study ID Numbers: 2PR2240936
Study First Received: December 2, 2010
Last Updated: November 15, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Aurolab:
PXF

Additional relevant MeSH terms:
Syndrome
Exfoliation Syndrome
Disease
Pathologic Processes
Iris Diseases
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014