h25 H26
Conditions
Interventions
Group 1: Patients enrolled in the study will be implanted in both eyes with the same Model ZXR00 lens following cataract surgery.
Sponsors
Abbott Medical Optics Inc.
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Inclusion criteria
Inclusion criteria: · Minimum 22 years of age · Planned natural lens replacement with posterior chamber IOL implantation · Visual potential of 20/25 or better in the operative eye following natural lens replacement with an IOL · Normal corneal topography · Clear intraocular media other than cataract in each eye · Availability, willingness, sufficient cognitive awareness to comply with examination procedures · Ability to sign informed consent
Exclusion criteria
Exclusion criteria: · Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D · Patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye · Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases · Expected surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss) · A compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible · Circumstances that would result in damage to the endothelium during implantation · Suspected microbial infection · Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL · Congenital bilateral cataracts · Previous history of, or a predisposition to, retinal detachment · Patients with only one good eye with potentially good vision · Medically uncontrollable glaucoma · Corneal endothelial dystrophy · Proliferative diabetic retinopathy · Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes · Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean binocular, photopic, uncorrected intermediate visual acuity (UCIVA) at 66 cm | — |
Secondary
| Measure | Time frame |
|---|---|
| · Mean binocular, photopic, uncorrected near visual acuity at 40 cm distance · Subjective evaluation of patient satisfaction via questionnaire | — |
Countries
Austria, Belgium, Croatia, France, Germany, Portugal, Spain, United Kingdom
Contacts
Public ContactRoland Pohl
AMO Germany GmbH
Outcome results
None listed