Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2009-11-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laser Treatment
LensAR Laser System
Use of laser for capsulotomy and lens fragmentation
Phacoemulsifcation
Conventional phacoemulsification
Use of standard techniques for capsulotomy and lens fragmentation
Interventions
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LensAR Laser System
Use of laser for capsulotomy and lens fragmentation
Conventional phacoemulsification
Use of standard techniques for capsulotomy and lens fragmentation
Eligibility Criteria
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Inclusion Criteria
* Subjects must have elected to undergo lens extraction and IOL implantation and then elect to have the LensAR laser surgery as part of the procedure.
* Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
* Subjects must have central 7 mm of clear cornea without vascularization.
Exclusion Criteria
* Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
* Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
* Subjects with macular degenerative pathology.
* Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
* Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
* Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
21 Years
ALL
No
Sponsors
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LensAR Incorporated
INDUSTRY
Responsible Party
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LensAR Incorporated
Locations
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Asociacion para Evitar la Ceguera en Mexico IAP
Mexico City, , Mexico
Countries
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Other Identifiers
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52-00006-000
Identifier Type: -
Identifier Source: org_study_id
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