A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
This study has been completed.
Information provided by:
LenSx Lasers Inc.
First received: August 12, 2009
Last updated: October 12, 2009
Last verified: October 2009
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 surface of the capsular bag that contains the cataractous crystalline lens. The objective of this study is to evaluate the ability of the LenSx 550 laser to successfully perform anterior capsulotomy during cataract surgery.
Device: LenSx 550 Laser System
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
Primary Outcome Measures:
- Capsulotomy is complete [ Time Frame: 1 day, 1 week, 1 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- No radial tears noted intraoperatively [ Time Frame: 1 day, 1 week, 1 month ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||24 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00959322
|Budapest, Hungary, 1085 |
LenSx Lasers Inc.
||Ronald M Kurtz, M.D.
||LenSx Lasers Inc.
||Melvin Sarayba, M.D.
||LenSx Lasers Inc.
No publications provided
||Dr. Melvin Sarayba, M.D., LenSx Lasers, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 12, 2009
||October 12, 2009
||Hungary: Institutional Ethics Committee
Keywords provided by LenSx Lasers Inc.:
ClinicalTrials.gov processed this record on November 25, 2014