Natural History of IOL in Pseudo Exfoliation Syndrome (PXF)

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

Study Overview

• Status: Unknown
• Conditions: Pseudo Exfoliation Syndrome
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • 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
      • Aravind Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

PXF subjects with or without glaucoma who require cataract surgery. Controls without PXF who require cataract surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: CTR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IOL Centration / IOL Stability	10th Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual Acuity	10th Year
Anterior capsular fibrosis/phimosis	10th Year
New onset of phacodonesis	10th Year
Development or worsening of glaucoma	10th Year

Collaborators and Investigators

• Sponsor: Aurolab
• Investigators: Principal Investigator: Haripriya Aravind, MS, Aravind Eye Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: December 7, 2010
• First Posted (Estimate): December 8, 2010

Study Record Updates

• Last Update Posted (Estimate): November 16, 2012
• Last Update Submitted That Met QC Criteria: November 15, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: PXF
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Uveal Diseases; Iris Diseases; Syndrome; Exfoliation Syndrome
• Other Study ID Numbers: 2PR2240936