Cataract
Conditions
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
Interventions
DEVICEStandard Monofocal Intraocular Lens
The control (active comparator) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a standard monofocal intraocular lens. Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis.
DEVICESynchrony® Dual Optic Intraocular Lens
The Synchrony® Dual Optic Intraocular Lens (experimantal) arm is comprised of patients who meet all study eligibility criteria and will be implanted with a Synchrony® Dual Optic Intraocular Lens. Each study patient will undergo standard extracapsular cataract extraction through a clear corneal or limbal incision and circular continuous curvilinear capsulorhexis.
Sponsors
Abbott Medical Optics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must be scheduled to undergo primary intraocular lens implantation for the correction of aphakia following extraction of a senile cataract. 2. Patients must have a cataract causing reduction in visual acuity to a level of 20/40 or worse with BAT on medium setting. 3. 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®). 4. Patients must have ≤ 1.0 D of preoperative keratometric astigmatism. 5. Patients must have clear intraocular media other than cataract(s). 6. Patients must be age 50 or older at the time of implantation. 7. Patient must be willing and able to return for all scheduled follow-up examinations and have signed a written informed consent form.
Exclusion criteria
1. Patients with any anterior segment pathology (anterior segment or corneal abnormalities, chronic uveitis, iritis, corneal dystrophy, pseudoexfoliation, etc.). 2. Patients with glaucoma, glaucoma suspect or ocular hypertension, i.e., IOP \> 22 mmHg. 3. Patients with previous retinal detachment or retinal pathology including age- related macular degeneration. 4. Patients with diabetes, currently being treated systemically. 5. Patients with systemic or ocular disease that may prevent the patient from achieving uncorrected distance visual acuity of 20/32 or better post operatively. 6. Patients with congenital bilateral cataract. 7. 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. 8. Patients with best corrected visual acuity of 20/80 or worse in the fellow eye not attributable to cataract. 9. Patients who are currently participating or have participated in an investigational study, other than this study, within the past 60 days. 10. Patients who have had previous ocular surgery in the operative eye, including refractive surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance corrected near visual acuity | 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected distance visual acuity | 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo |
Countries
United States
Outcome results
None listed