search
Back to results

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

Primary Purpose

Cataract

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Standard Monofocal Intraocular Lens
Synchrony® Dual Optic Intraocular Lens
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harvard Eye Associates
  • Long Beach Laser Center
  • Altos Eye Physicians
  • Grutzmacher & Lewis
  • Davidorf Eye Group
  • Glaucoma Consultants of Colorado
  • Katzen Eye Care and Laser Center
  • EyeSight Hawaii
  • The Midwest Center for Sight
  • NorthShore University HealthSystem
  • Wallace Eye Surgery
  • Chu Vision Institute
  • Associated Eye Care
  • Pepose Vision Institute
  • Nevada Eye Care
  • Drs. Fine, Hoffman & Packer
  • Alkek Eye Center
  • University of Utah Hospitals and Clinics
  • Northwest Eye Surgeons
  • Davis Duehr Dean

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Synchrony® Dual Optic Intraocular Lens

Standard Monofocal Intraocular Lens

Arm Description

Outcomes

Primary Outcome Measures

Distance corrected near visual acuity

Secondary Outcome Measures

Best corrected distance visual acuity

Full Information

First Posted
January 19, 2007
Last Updated
September 16, 2013
Sponsor
Abbott Medical Optics
search

1. Study Identification

Unique Protocol Identification Number
NCT00425464
Brief Title
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
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 Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synchrony® Dual Optic Intraocular Lens
Arm Type
Experimental
Arm Title
Standard Monofocal Intraocular Lens
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Standard Monofocal Intraocular Lens
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Synchrony® Dual Optic Intraocular Lens
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distance corrected near visual acuity
Time Frame
1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Secondary Outcome Measure Information:
Title
Best corrected distance visual acuity
Time Frame
1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Long Beach Laser Center
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Altos Eye Physicians
City
Los Altos
State/Province
California
ZIP/Postal Code
94024
Country
United States
Facility Name
Grutzmacher & Lewis
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Davidorf Eye Group
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Glaucoma Consultants of Colorado
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Katzen Eye Care and Laser Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
EyeSight Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
The Midwest Center for Sight
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Name
NorthShore University HealthSystem
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Wallace Eye Surgery
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71303
Country
United States
Facility Name
Chu Vision Institute
City
Bloomington
State/Province
Minnesota
Country
United States
Facility Name
Associated Eye Care
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Pepose Vision Institute
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Nevada Eye Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
Drs. Fine, Hoffman & Packer
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Alkek Eye Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Northwest Eye Surgeons
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Davis Duehr Dean
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs