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

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00425464
• Collaborator: (none)
• Enrollment: 410
• Locations: 20
• Arms: 2
• Duration (Months): 89
• Patients Per Site: 20.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Standard Monofocal Intraocular Lens; Device: Synchrony® Dual Optic Intraocular Lens	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 410 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Synchrony® Dual Optic Intraocular Lens	Device: 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.
Active Comparator: Standard Monofocal Intraocular Lens	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.

Outcome Measures

Primary Outcome Measures

1. Distance corrected near visual acuity [1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo]

Secondary Outcome Measures

1. Best corrected distance visual acuity [1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard Eye Associates	Laguna Hills	California	United States	92653
2	Long Beach Laser Center	Los Alamitos	California	United States	90720
3	Altos Eye Physicians	Los Altos	California	United States	94024
4	Grutzmacher & Lewis	Sacramento	California	United States	95815
5	Davidorf Eye Group	West Hills	California	United States	91307
6	Glaucoma Consultants of Colorado	Parker	Colorado	United States	80134
7	Katzen Eye Care and Laser Center	Boynton Beach	Florida	United States	33426
8	EyeSight Hawaii	Honolulu	Hawaii	United States	96817
9	The Midwest Center for Sight	Des Plaines	Illinois	United States	60016
10	NorthShore University HealthSystem	Glenview	Illinois	United States	60026
11	Wallace Eye Surgery	Alexandria	Louisiana	United States	71303
12	Chu Vision Institute	Bloomington	Minnesota	United States
13	Associated Eye Care	Stillwater	Minnesota	United States	55082
14	Pepose Vision Institute	Chesterfield	Missouri	United States	63017
15	Nevada Eye Care	Las Vegas	Nevada	United States	89129
16	Drs. Fine, Hoffman & Packer	Eugene	Oregon	United States	97401
17	Alkek Eye Center	Houston	Texas	United States	77030
18	University of Utah Hospitals and Clinics	Salt Lake City	Utah	United States	84132
19	Northwest Eye Surgeons	Seattle	Washington	United States	98133
20	Davis Duehr Dean	Madison	Wisconsin	United States	53715

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT00425464
• Other Study ID Numbers: SYNC-601-IOL
• First Posted: Jan 23, 2007
• Last Update Posted: Sep 19, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Sep 19, 2013