NCT01061281CompletedPhase 4
Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Innovative Medical
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Refraction
Study Overview
Brief Summary
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months after post cataract surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 or greater
- •Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
- •Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
- •Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
- •Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for both eyes
- •Preoperative corneal astigmatism of 1.0 D or less
- •Clear intraocular media other than cataract
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria
- •Use of systemic or ocular medications that may affect vision
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- •Subjects with diabetes mellitus
- •Uncontrolled systemic or ocular disease
- •History of ocular trauma or prior ocular surgery
- •Amblyopia or strabismus
- •Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- •Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
- •Subjects who may be expected to require retinal laser treatment or other surgical intervention
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- •Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
- •Requiring an intraocular lens < 15.0 or > 26.0 diopters
Arms & Interventions
Tecnis MF IOL
Active Comparator
Intervention: Tecnis MF IOL (Device)
Crystalens AO IOL
Active Comparator
Intervention: Crystalens AO IOL (Device)
Outcomes
Primary Outcomes
Refraction
Time Frame: 1 year
Distance Visual Acuities
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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