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

Rayner Intraocular Lenses

Status

Withdrawn

Conditions

Cataract

Treatments

Device: 600S

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02378636

600C-EU-401

CFLX-2501 (Other Identifier)

Details and patient eligibility

About

This will be a prospective, open-label, 125 subject (maximum), two-year multicentre investigation to assess the safety, effectiveness and rotational stability of the modified 600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.