Post-market clinical follow-up investigation of the marketed Extended Range of Vision IOL (Intraocular lens)

Not Applicable

• Conditions: h25; H26; Senile cataract; Other cataract

• Registration Number: DRKS00005742
• Lead Sponsor: Abbott Medical Optics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-25
• Study Completion: 2015-10-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 147

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

· 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean binocular, photopic, uncorrected intermediate visual acuity (UCIVA) at 66 cm

Secondary Outcome Measures

Name	Time	Method
· Mean binocular, photopic, uncorrected near visual acuity at 40 cm distance<br>· Subjective evaluation of patient satisfaction via questionnaire