A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction

Cataract Clinical Trial

Official title:

A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00425464
• Other study ID #: SYNC-601-IOL
• Status: Terminated
• Phase: Phase 3
• First received: January 19, 2007
• Last updated: September 16, 2013
• Start date: November 2005
• Est. completion date: April 2013

Study information

• Verified date: September 2013
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 410
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Standard 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.
• Synchrony® 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.

Locations

Country	Name	City	State
United States	Wallace Eye Surgery	Alexandria	Louisiana
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Katzen Eye Care and Laser Center	Boynton Beach	Florida
United States	Pepose Vision Institute	Chesterfield	Missouri
United States	The Midwest Center for Sight	Des Plaines	Illinois
United States	Drs. Fine, Hoffman & Packer	Eugene	Oregon
United States	NorthShore University HealthSystem	Glenview	Illinois
United States	EyeSight Hawaii	Honolulu	Hawaii
United States	Alkek Eye Center	Houston	Texas
United States	Harvard Eye Associates	Laguna Hills	California
United States	Nevada Eye Care	Las Vegas	Nevada
United States	Long Beach Laser Center	Los Alamitos	California
United States	Altos Eye Physicians	Los Altos	California
United States	Davis Duehr Dean	Madison	Wisconsin
United States	Glaucoma Consultants of Colorado	Parker	Colorado
United States	Grutzmacher & Lewis	Sacramento	California
United States	University of Utah Hospitals and Clinics	Salt Lake City	Utah
United States	Northwest Eye Surgeons	Seattle	Washington
United States	Associated Eye Care	Stillwater	Minnesota
United States	Davidorf Eye Group	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance corrected near visual acuity		1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo	No
Secondary	Best corrected distance visual acuity		1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo	No