Evaluation of An Intra-Operative Toric Intraocular Lens Alignment System - CALZ-3001

Carl Zeiss Meditec AG - Site Munich0 sites71 target enrollmentJuly 1, 2013

Overview

No summary available.

Registry

who.int

Start Date

July 1, 2013

End Date

July 18, 2015

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Carl Zeiss Meditec AG - Site Munich

•Cataract, for which phacoemulsification and posterior chamber IOL implantation has been planned in the operative eye OR.
•Clear crystalline lens, for which the subject has elected to undergo ‘refractive lens exchange’, with planned phacoemulsification and posterior chamber IOL implantation in the operative eye.
•Patient age \= 21 years.
•Pre\-operative corneal astigmatism \=1\.00 D
•The subject must be able to provide written Informed Consent.
•The subject must be able to return for the scheduled follow up examinations one week and six weeks after surgery.
•Normal anterior and posterior segments.
•Clear intraocular media – other than cataract.

•Corneal ectasia\* (e.g. Keratoconus, Pellucid Marginal Corneal Degeneration or Keratoglobus)
•Peripheral corneal thinning disorders\* (e.g. Mooren’s Ulcer or Terrien’s marginal degeneration)
•Any forms of corneal pathology potentially affecting topography.
•Any previous history of ocular trauma or prior ocular surgery (including previous cataract surgery and CLRIs)\*.
•Subjects with diagnosed degenerative visual disorders \* (for example macular degeneration or any other retinal disorders) that are predicted to cause future acuity losses.
•Capsular/zonular lens abnormalities\* that may affect post\-operative IOL centration and/or tilt
•Microphthalmia\*.
•Active ocular disease\*, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency (such as Fuch’s endothelial dystrophy).
•Cornea dystrophy\*, guttata\* or oedema\*.
•Previous corneal graft/keratoplasty.