Clinical Outcomes of the Use of a Femtosecond Laser on an Implanted Intraocular Lens

A Prospective Study to Assess the Clinical and Refractive Outcomes of the Use of a Femtosecond Laser on an Implanted Intraocular Lens

This is a prospective non-randomized patient controlled single center study which is designed to evaluate the clinical outcomes of the treatment of an implanted intraocular lens using a low-energy femtosecond laser for refractive correction.

The purpose of this research study is to evaluate the safety and efficacy of the treatment of an implanted intraocular lens with a device. The device employs a generic femtosecond laser used in numerous other ophthalmic procedures. The device uses low levels of energy from the femtosecond laser to correct spherical, cylindrical and sphero-cylindrical refractive error existing in an implanted intraocular lens. The refractive correction is effected through the treatment, which is employed at least 30 days after cataract surgery.

Inclusion Criteria:

1. Ability to understand study requirements, follow study instructions and to return for required study follow-up visits as confirmed by provision of written informed consent.
2. Subject has undergone cataract surgery and has had an AMO ZCB00/PCB00/AAB00 in at least one eye (only one eye will be treated).
3. Subject has post-operative refractive error of one diopter or more of spherical, cylinder or sphero-cylinder difference from desired refraction.
4. 20/40 or better BCDVA at 4m.

Exclusion Criteria:

1. Subject not able to complete the informed consent form.
2. Astigmatism greater than 3 diopter.
3. Spherical diopter error of greater than 4 diopters.
4. Combined spherical and cylinder diopter error of greater than 5 diopters.
5. Clinically significant corneal abnormalities including corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy), inflammation, keratitis, keratoconjunctivitis, keratouveitis, keratopathy, keratectasia or edema per the Investigator's expert medical opinion.
6. Previous corneal transplant.
7. Previous refractive surgery or proposed refractive surgery procedures throughout the entire duration of the subject's participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions).
8. History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that the Investigator judges could confound outcomes, including but not limited to background diabetic retinopathy, diabetic macular edema or proliferative diabetic retinopathy, macular degeneration.
9. Amblyopia.
10. History of or current anterior or posterior segment inflammation of any etiology, or any disease producing an inflammatory reaction in the eye (e.g. iritis or uveitis).
11. Glaucoma.
12. Optic nerve atrophy.
13. Iris neovascularization.
14. Subjects with diagnosed degenerative eye disorders (e.g. macular degeneration or other retinal disorders).
15. Any subject currently participating in another investigational drug or device study.