Status:
COMPLETED
Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
Lead Sponsor:
Abbott Medical Optics
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00747227
Start Date
December 1 2006
End Date
June 1 2009
Last Update
November 11 2011
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Patrick Aiello, M.D.
Scottsdale, Arizona, United States, 85054
2
Randall E. Cole, M.D.
Rogers, Arkansas, United States, 72756
3
Aron Rose, M.D.
New Haven, Connecticut, United States, 06510
4
Y. Ralph Chu, M.D.
Bloomington, Minnesota, United States, 55420