PXF: Natural History of IOL in Pseudo Exfoliation Syndrome

• Sponsor: Aurolab (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01255995
• Collaborator: (none)
• Enrollment: 1,500
• Locations: 4
• Duration (Months): 137
• Patients Per Site: 375
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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: Dec 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. IOL Centration / IOL Stability [10th Year]

Secondary Outcome Measures

1. Visual Acuity [10th Year]

2. Anterior capsular fibrosis/phimosis [10th Year]

3. New onset of phacodonesis [10th Year]

4. Development or worsening of glaucoma [10th Year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Aravind Eye Hospital	Coimbatore	Tamil Nadu	India	641014
2	Aravind Eye Hospital	Madurai	Tamil Nadu	India	625020
3	Aravind Eye Hospital	Pondicherry	Tamil Nadu	India	605 007
4	Aravind Eye Hospital	Tirunelveli	Tamil Nadu	India	627001

Sponsors and Collaborators

• Aurolab

Investigators

• Principal Investigator: Haripriya Aravind, MS, Aravind Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aurolab
• ClinicalTrials.gov Identifier: NCT01255995
• Other Study ID Numbers: 2PR2240936
• First Posted: Dec 8, 2010
• Last Update Posted: Nov 16, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Aurolab: PXF
• Additional relevant MeSH terms: Exfoliation Syndrome; Syndrome

Study Results

No Results Posted as of Nov 16, 2012