Status:
COMPLETED
A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
Lead Sponsor:
LenSx Lasers Inc.
Conditions:
Cataract
Eligibility:
All Genders
24+ years
Phase:
NA
Brief Summary
The LenSx 550 laser system is a femtosecond laser intended for use in performing anterior capsulotomy during cataract surgery. The anterior capsulotomy creates a circular opening in the anterior surfa...
Eligibility Criteria
Inclusion
- Must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
- Must be at least 24 years of age.
- Must be willing and able to return for scheduled follow-up examinations.
- Subjects must sign and be given a copy of the written Informed Consent form.
Exclusion
- Corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
- Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally are excluded.
- Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye are excluded.
- History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP\>21 mm Hg in either eye.
- Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
- Known sensitivity to planned study concomitant medications.
- Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
- Subjects presenting any contraindications to cataract surgery.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00959322
Start Date
August 1 2008
End Date
March 1 2009
Last Update
October 14 2009
Active Locations (1)
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1
Semmelweis University
Budapest, Hungary, 1085