Natural History of IOL in Pseudo Exfoliation Syndrome

Pseudo Exfoliation Syndrome Clinical Trial

— PXF  

Official title:

The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01255995
• Other study ID #: 2PR2240936
• Status: Active, not recruiting
• Phase: N/A
• First received: December 2, 2010
• Last updated: November 15, 2012
• Start date: December 2010
• Est. completion date: May 2022

Study information

• Verified date: November 2012
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: May 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Pseudo Exfoliation Syndrome
• Syndrome

Intervention

Device:
• Capsular Tension Ring
Capsular Tension Ring

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Coimbatore	Tamil Nadu
India	Aravind Eye Hospital	Madurai	Tamil Nadu
India	Aravind Eye Hospital	Pondicherry	Tamil Nadu
India	Aravind Eye Hospital	Tirunelveli	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOL Centration / IOL Stability		10th Year	No
Secondary	Visual Acuity		10th Year	No
Secondary	Anterior capsular fibrosis/phimosis		10th Year	No
Secondary	New onset of phacodonesis		10th Year	Yes
Secondary	Development or worsening of glaucoma		10th Year	Yes