Clinical trial NCT00747227: Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
Official title: Clinical Evaluation of a Modified Light Transmission IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: cataract
monofocal
intraocular lens
acrylic
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of a new investigational modified light transmission monofocal intraocular lens compared to a conventional intraocular lens (IOL).

Detailed description: The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.

Eligibility criteria: Inclusion Criteria:

* Age 18 years of age or older
* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned
* Visual potential in both eyes of 20/30 Snellen or better after cataract removal and IOL implantation
* Preoperative corneal astigmatism of 1.5 diopters or less

Exclusion Criteria:

* Use of systemic or ocular medications that may affect vision
* Uncontrolled systemic or recurrent ocular disease
* Requiring an intraocular lens \<15.0 or \>26.0 diopters
* Abnormal results with the Farnsworth-Munsell D-15 and/or Ishihara color plates
* History of ocular trauma or prior ocular surgery
* Known pathology that may affect visual acuity or visual field
* Corneal abnormalities
* Pupil abnormalities
* Capsule or zonular abnormalities

Primary outcomes:
measure: Best Corrected Distance Visual Acuity
timeFrame: One year
measure: Uncorrected Distance Visual Acuity
timeFrame: One Year
Secondary outcomes:
measure: Contrast Sensitivity
timeFrame: 4-6 months
measure: Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".
timeFrame: One Year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Patrick Aiello, M.D.
state: Arizona
city: Rogers
country: United States
facility: Randall E. Cole, M.D.
state: Arkansas
city: New Haven
country: United States
facility: Aron Rose, M.D.
state: Connecticut
city: Bloomington
country: United States
facility: Y. Ralph Chu, M.D.
state: Minnesota
city: Kansas City
country: United States
facility: Steven Silverstein, M.D.
state: Missouri
city: Roseburg
country: United States
facility: Jon-Marc Weston, M.D.
state: Oregon
city: Cranberry Township
country: United States
facility: William Christie, M.D.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mark Blecher, M.D.
state: Pennsylvania
city: Providence
country: United States
facility: Robert L. Bahr, M.D.
state: Rhode Island
city: Sioux Falls
country: United States
facility: Vance Thompson, M.D.
state: South Dakota
city: Lacey
country: United States
facility: Jay Rudd, M.D.
state: Washington
Study officials:
affiliation: University of California, Irvine, Dept. of Ophthalmology
name: Roger F. Steinert, M.D.
role: PRINCIPAL_INVESTIGATOR
References: