Natural History of IOL in Pseudo Exfoliation Syndrome
PXF
The Natural History of Artificial Intraocular Lenses (IOL) in Eyes With Exfoliation Syndrome
1 other identifier
observational
1,500
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 2, 2010
CompletedFirst Posted
Study publicly available on registry
December 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedNovember 16, 2012
November 1, 2012
11 years
December 2, 2010
November 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IOL Centration / IOL Stability
10th Year
Secondary Outcomes (4)
Visual Acuity
10th Year
Anterior capsular fibrosis/phimosis
10th Year
New onset of phacodonesis
10th Year
Development or worsening of glaucoma
10th Year
Study Arms (2)
Control Patients
Controls without PXF who require cataract surgery
Pseudo Exfoliation patients
PXF subjects with or without glaucoma who require cataract surgery
Interventions
Eligibility Criteria
PXF subjects with or without glaucoma who require cataract surgery. Controls without PXF who require cataract surgery
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aurolablead
Study Sites (4)
Aravind Eye Hospital
Coimbatore, Tamil Nadu, 641014, India
Aravind Eye Hospital
Madurai, Tamil Nadu, 625020, India
Aravind Eye Hospital
Pondicherry, Tamil Nadu, 605 007, India
Aravind Eye Hospital
Tirunelveli, Tamil Nadu, 627001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haripriya Aravind, MS
Aravind Eye Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2010
First Posted
December 8, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2021
Study Completion
May 1, 2022
Last Updated
November 16, 2012
Record last verified: 2012-11