Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
- Conditions
- Cataract
- Interventions
- Device: modified light transmission intraocular lensDevice: monofocal acrylic intraocular lens
- Registration Number
- NCT00747227
- Lead Sponsor
- Abbott Medical Optics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZV9003 modified light transmission intraocular lens modified light transmission intraocular lens ZA9003 monofocal acrylic intraocular lens monofocal acrylic intraocular lens
- Primary Outcome Measures
Name Time Method Best Corrected Distance Visual Acuity One year Snellen Equivalent visual acuity of 20/40 or better
Uncorrected Distance Visual Acuity One Year Snellen Equivalent of 20/40 or better at one year
- Secondary Outcome Measures
Name Time Method Contrast Sensitivity 4-6 months Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.
Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent". One Year Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit.
Trial Locations
- Locations (11)
Robert L. Bahr, M.D.
🇺🇸Providence, Rhode Island, United States
Patrick Aiello, M.D.
🇺🇸Scottsdale, Arizona, United States
Aron Rose, M.D.
🇺🇸New Haven, Connecticut, United States
Steven Silverstein, M.D.
🇺🇸Kansas City, Missouri, United States
Mark Blecher, M.D.
🇺🇸Philadelphia, Pennsylvania, United States
Randall E. Cole, M.D.
🇺🇸Rogers, Arkansas, United States
Jay Rudd, M.D.
🇺🇸Lacey, Washington, United States
Y. Ralph Chu, M.D.
🇺🇸Bloomington, Minnesota, United States
Jon-Marc Weston, M.D.
🇺🇸Roseburg, Oregon, United States
William Christie, M.D.
🇺🇸Cranberry Township, Pennsylvania, United States
Vance Thompson, M.D.
🇺🇸Sioux Falls, South Dakota, United States