Status:
UNKNOWN
Natural History of IOL in Pseudo Exfoliation Syndrome
Lead Sponsor:
Aurolab
Conditions:
Pseudo Exfoliation Syndrome
Eligibility:
All Genders
18+ years
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 p...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT01255995
Start Date
December 1 2010
End Date
May 1 2022
Last Update
November 16 2012
Active Locations (4)
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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