Feasibility Study of Laser Treatment of the Crystalline Lens to Correct Presbyopia

Inclusion Criteria:

• Subjects must sign and be given a copy of the written informed consent form.
• Subjects must have elected to undergo lens extraction and IOL implantation to treat their ocular disorder then elect to have the LensAR laser surgery as part of the procedure.
• Cataract should not exceed LOCS III Grade 2.
• Subjects must have best corrected distance visual acuity of 20/40 or better in the eye to be treated .
• Subjects must be ≥ 45 years and ≤ 60 years of age at time of subject eligibility visit.
• Subjects must be willing and able to return for scheduled follow up examinations for 6 months after cataract surgery or up to 3 years (at 6 month intervals) if no cataract surgery is performed.
• Subject must have central 7 mm of clear cornea without vascularization

Exclusion Criteria:

• Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
• Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
• Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
• Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
• Subjects with macular degenerative pathology.
• Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
• Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
• Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
• Subjects who cannot attain ocular dilation adequate to allow laser treatment within the minimum range based on the laser procedure to be applied.
• Subjects with known sensitivity to planned study concomitant medications.
• Subjects using systemic medication that is known to reduce the amplitude of accommodation (such as medication for motion sickness containing hyoscine or other antimuscarinic drugs, anticholinergic drugs, anti-psychotic drugs, tricyclic antidepressants and other drugs acting on the central nervous system).
• Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.