Clinical Evaluation of a Modified Light Transmission IOL
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Abbott Medical Optics
- Enrollment
- 250
- Locations
- 11
- Primary Endpoint
- Best Corrected Distance Visual Acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
ZV9003
modified light transmission intraocular lens
Intervention: modified light transmission intraocular lens (Device)
ZA9003
monofocal acrylic intraocular lens
Intervention: monofocal acrylic intraocular lens (Device)
Outcomes
Primary Outcomes
Best Corrected Distance Visual Acuity
Time Frame: One year
Snellen Equivalent visual acuity of 20/40 or better
Uncorrected Distance Visual Acuity
Time Frame: One Year
Snellen Equivalent of 20/40 or better at one year
Secondary Outcomes
- Contrast Sensitivity(4-6 months)
- Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent".(One Year)