Phase 3
N=250
Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00747227 ↗Enrolled (actual)
250
Serious AEs
0.8%
Results posted
Nov 2011
Primary outcome: Primary: Best Corrected Distance Visual Acuity — 119; 120 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- modified light transmission intraocular lens (Device); monofocal acrylic intraocular lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Optics
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Corrected Distance Visual Acuity |
119; 120 | — |
| PRIMARY Uncorrected Distance Visual Acuity |
110; 116 | — |
| SECONDARY Contrast Sensitivity |
1.62; 1.62; 1.65; 1.63; 1.14; 1.17 | — |
| SECONDARY Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent". |
112; 113 | — |
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).
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 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
Data sourced from ClinicalTrials.gov (NCT00747227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.