None listed
Conditions
Brief summary
The LenSx laser system is a femtosecond laser that has received 510(k) clearance (USA FDA) for anterior capsulotomy during cataract surgery, laser phacofragmentation during cataract surgery and for use in the creation of a single and multi-plan arc cut/incisions in the cornea. During cataract surgery, the LenSx Laser creates corneal incisions to allow the surgeon to enter the anterior chamber of the eye. It also creates a circular incision on the anterior capsule at a pre-programmed diameter to allow the surgeon to remove the cataractous lens. Lastly, the laser creates incisions within the cataractous crystalline lens to create fragmented pieces that are easy to manipulate, emulsify and aspirate with a phacoemulsification device. The objective of this study is to observe the performance of the cleared 510(k) device by assessing the laser created anterior capsulotomy, phacofragmentation, and/or corneal incisions when attempted, as well as to compare standard visual outcomes and commercial experience between laser and manual completion of standard cataract surgery procedures.
Interventions
The objective of this evaluation is to observe the performance of the Femtosecond Cataract Laser (LenSx Alcon) by assessing the performance of the following applications; laser created anterior capsulotomy, phacofragmentation, and/or corneal incisions, as well as to compare standard visual outcomes and commercial experience between laser and traditional manual cataract surgery procedures.
The laser procedure is assisting the removal of cataracts. Cataracts cause visual loss. Previous studies ha
The objective of this evaluation is to observe the performance of the Femtosecond Cataract Laser (LenSx Alcon) by assessing the performance of the following applications; laser created anterior capsulotomy, phacofragmentation, and/or corneal incisions, as well as to compare standard visual outcomes and commercial experience between laser and traditional manual cataract surgery procedures. The laser procedure is assisting the removal of cataracts. Cataracts cause visual loss. Previous studies have shown that removing the cataract and implanting a new intraocular lens rehabilitate the patient's vision and may increase the patient’s quality of life. The LenSx (Registered Trademark) Laser works by creating incisions through tightly focused femtosecond laser pulses that cut tissue with micron-scale precision. Further laser pulses are able to create the capsule and break up the existing or natural lens. The Laser replaces a combination of equipment including a blade to create the manual incisions, a needle to help open the capsule which then allows for the lens/cataract to be removed by the use with an external phaco emulsification unit. In this study each patient will undergo each available application in order to fully assess the impact on safety and accuracy that the LenSx may provide in comparison to the manual (control) technique. The duration of the Femtosecond laser is approximately 3 minutes. The subsequent removal of the lens and replacement by the new artifical lens commonly takes approximately 10 further minutes although there is a break to transport the patient across to the operating suite.
Sponsors
Vision Eye Institute Chatswood
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
24 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye. 2. Subjects must be willing and able to return for scheduled follow-up examinations. 3. Subjects must sign and be given a copy of the written Informed Consent form.
Exclusion criteria
1. Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye. 2. Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study. 3. Subjects with known sensitivity to planned study concomitant medications. 4. Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation. 5. Subjects presenting any contraindications to cataract surgery. 6. Hypotony, glaucoma, or the presence of a corneal implant. 7. Presence of blood or other material in the anterior chamber. 8. Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease). 9. A history of lens or zonular instability. Exclusion For Laser Group Only 10. Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength. 11. Corneal opacity that would interfere with the laser beam. 12. Descemetocele with impending corneal rupture. 13. Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy. 14. Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only). 15. Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape. 16. Corneal thickness requirements that are beyond the range of the system (>1500 microns).
Outcome results
None listed