Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens

This is an interventional treatment trial for Cataract Read More

Inclusion Criteria:

• Male or female aged ≥21 years of age.
• Cataract for which phacoemulsification extraction and posterior IOL implantation has been planned for the operative eye.
• Best corrected distance visual acuity (BCDVA) projected to be better than 20/30 (+0.18 logMAR) in the operative eye after cataract removal and IOL implantation.
• Calculated IOL power requirement within the range +8.0 to +34.0D
• If present, subject must have corneal astigmatism of <1.50 D in the operative eye.
• Expected dilated pupil size ≥ 5.0 mm in diameter to visualise the axis markings
• Subject must provide written informed consent.
• Subject must be able to return for scheduled follow-up examinations for 24 months after surgery.

Exclusion Criteria:

• History of ocular trauma or prior ocular surgery in the operative eye.
• Microphthalmia
• Corneal decompensation or endothelial insufficiency
• Pseudo exfoliation
• Pars planitis
• Subjects with diagnosed degenerative visual disorders in the operative eye (e.g.,macular degeneration or other retinal disorders) that are predicted to cause future visual acuity losses to a level of 20/30 (+0.18 logMAR) or worse.
• Inability to achieve secure placement in the designated location e.g. absence of a secure peripheral anterior capsule, zonule laxity or dehiscence; posterior synechiae to the capsular bag
• Active ocular disease in the operative eye, e.g., clinically significant dystrophy, chronic severe uveitis, proliferative diabetic retinopathy, or chronic glaucoma.
• Concurrent participation in another drug or device investigation.
• Patients who are expected to require retinal laser treatment.
• Females who are pregnant, nursing or plan to become pregnant during the study.