NCT00425464TerminatedPhase 3
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Abbott Medical Optics
- Enrollment
- 410
- Locations
- 39
- Primary Endpoint
- Distance corrected near visual acuity
Study Overview
Brief Summary
The purpose of the study is to determine if the Synchrony Dual Optic Accommodating Intraocular Lens can be used safely and effectively in post cataract extraction subjects
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must be scheduled to undergo primary intraocular lens implantation for the correction of aphakia following extraction of a senile cataract.
- •Patients must have a cataract causing reduction in visual acuity to a level of 20/40 or worse with BAT on medium setting.
- •Patients must require Synchrony® Lens correction of 16D - 28D or, if participating in the control study, patients must require a Clariflex® (AMO®), Phacoflex® II models SI30NB (AMO®) or a SI40NB (AMO®).
- •Patients must have ≤ 1.0 D of preoperative keratometric astigmatism.
- •Patients must have clear intraocular media other than cataract(s).
- •Patients must be age 50 or older at the time of implantation.
- •Patient must be willing and able to return for all scheduled follow-up examinations and have signed a written informed consent form.
Exclusion Criteria
- •Patients with any anterior segment pathology (anterior segment or corneal abnormalities, chronic uveitis, iritis, corneal dystrophy, pseudoexfoliation, etc.).
- •Patients with glaucoma, glaucoma suspect or ocular hypertension, i.e., IOP > 22 mmHg.
- •Patients with previous retinal detachment or retinal pathology including age- related macular degeneration.
- •Patients with diabetes, currently being treated systemically.
- •Patients with systemic or ocular disease that may prevent the patient from achieving uncorrected distance visual acuity of 20/32 or better post operatively.
- •Patients with congenital bilateral cataract.
- •Patients who require chronic administration of any topical ophthalmic or systemic medication that may affect accommodation such as mydriatic, cycloplegic and myotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, anticholinergic agents. The use of tamsulosin hydrochloride (Flomax®) is also excluded preoperatively due to floppy iris syndrome.
- •Patients with best corrected visual acuity of 20/80 or worse in the fellow eye not attributable to cataract.
- •Patients who are currently participating or have participated in an investigational study, other than this study, within the past 60 days.
- •Patients who have had previous ocular surgery in the operative eye, including refractive surgery.
Outcomes
Primary Outcomes
Distance corrected near visual acuity
Time Frame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Secondary Outcomes
- Best corrected distance visual acuity(1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo)
Investigators
Study Sites (39)
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