Cataract
Conditions
Keywords
Capsulotomy
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 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.
Interventions
DEVICELenSx 550 Laser System
Femtosecond laser used to create capsulotomy incision.
Sponsors
LenSx Lasers Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Capsulotomy is complete | 1 day, 1 week, 1 month |
Secondary
| Measure | Time frame |
|---|---|
| No radial tears noted intraoperatively | 1 day, 1 week, 1 month |
Countries
Hungary
Outcome results
None listed