Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery

Inclusion criteria

• Subject must be aged ≥ 21 years at the time of eligibility visit.
• Subject must have a vector difference of 0.50 D or less in magnitude of pre-operative anterior corneal astigmatism as measured by the Pentacam AXL and the Zeiss IOLMaster 700 (Carl Zeiss Meditec).
• Subject must be able and willing to comply with the study examination procedures.
• Astigmatic treatment must require paired arcs <45mm in length.
• Subject must be willing to complete the approved informed consent form.
• Subject must have elected to undergo lens extraction and Light Adjustable Lens (LAL) implantation.
• Subject must be willing and able to return for scheduled pre-op and follow-up examinations.
• Subject must have central 7 mm of clear cornea without vascularization.

Exclusion criteria

• Subject who has undergone previous corneal or intraocular surgery in the eye to be treated.
• Subject with a history, signs or symptoms of ocular disease or atypical findings that would be contraindicated under standard of care for lens extraction surgery.
• Subject with neuro-ophthalmic disease.
• Diabetic or hypertensive subject with clinical evidence of retinal pathology that the investigator believes will significantly affect visual outcomes.
• Subject with macular degenerative pathology identified at the preoperative visit that the investigator believes will significantly affect visual outcomes.
• Subject with a history of steroid-responsive rise in intraocular pressure (IOP), preoperative IOP >25 mmHg, or uncontrolled glaucoma in either eye.
• Subject with known lens/zonular instability.
• Subject who cannot achieve dilated pupillary diameter > 6 mm.
• Subject with abnormal corneal topography, including evidence of forme fruste keratoconus, keratoconus or pellucid marginal degeneration.
• Subject with posterior segment disease or degeneration.
• Subject with corneal disease or pathology that precludes an adequate view for imaging or transmission of laser wavelength of light.
• Subject with known sensitivity to planned perioperative standard of care medications.
• Subject participating in any other ophthalmic drug or device clinical trial during the time of this clinical assessment.
• Subject with known sensitivity to planned assessment concomitant medications.
• Subjects with severe dry eye syndrome (DES) or history of ocular inflammation that may impact visual outcomes.
• Subject with irregular astigmatism in the eye to be treated.