CataractPhase 3NCT00425464
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction
A Phase 3 study testing Standard Monofocal Intraocular Lens and Synchrony® Dual Optic Intraocular Lens in people with Cataract, run by Abbott Medical Optics at 20 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Standard Monofocal Intraocular Lens and Synchrony® Dual Optic Intraocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 20 sitesUnited States
- Study dates
- Nov 2005to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Wallace Eye Surgery
Alexandria, Louisiana, 71303
Chu Vision Institute
Bloomington, Minnesota
Katzen Eye Care and Laser Center
Boynton Beach, Florida, 33426
Pepose Vision Institute
Chesterfield, Missouri, 63017
The Midwest Center for Sight
Des Plaines, Illinois, 60016
Drs. Fine, Hoffman & Packer
Eugene, Oregon, 97401
NorthShore University HealthSystem
Glenview, Illinois, 60026
EyeSight Hawaii
Honolulu, Hawaii, 96817
Alkek Eye Center
Houston, Texas, 77030
Harvard Eye Associates
Laguna Hills, California, 92653
Nevada Eye Care
Las Vegas, Nevada, 89129
Long Beach Laser Center
Los Alamitos, California, 90720
Altos Eye Physicians
Los Altos, California, 94024
Davis Duehr Dean
Madison, Wisconsin, 53715
Glaucoma Consultants of Colorado
Parker, Colorado, 80134
Grutzmacher & Lewis
Sacramento, California, 95815
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
Northwest Eye Surgeons
Seattle, Washington, 98133
Associated Eye Care
Stillwater, Minnesota, 55082
Davidorf Eye Group
West Hills, California, 91307
About this study
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
- Conditions
- Cataract
- Being tested
- Standard Monofocal Intraocular Lens, Synchrony® Dual Optic Intraocular Lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Monofocal Intraocular LensDevice
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 LensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Synchrony® Dual Optic Intraocular Lens | Experimental | Not described Receives: Device: Synchrony® Dual Optic Intraocular Lens |
| Standard Monofocal Intraocular Lens | Active comparator | Not described Receives: Device: Standard Monofocal Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance corrected near visual acuity
Measured: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Secondary outcomes (1)
Best corrected distance visual acuity
Measured: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startNov 2005
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425464
- Sponsor's protocol ID
- SYNC-601-IOL
- Status last verified
- Sep 2013
- First submitted
- 19 Jan 2007
- Last updated
- 19 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00425464
- Acronym / sponsor ID
- SYNC-601-IOL
- Conditions
- Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synchrony® Dual Optic Intraocular Lens | Experimental | Device: Synchrony® Dual Optic Intraocular Lens |
| Standard Monofocal Intraocular Lens | Active comparator | Device: Standard Monofocal Intraocular Lens |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Monofocal Intraocular LensThe 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. | Device | Standard Monofocal Intraocular Lens |
| Synchrony® Dual Optic Intraocular LensThe 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. | Device | Synchrony® Dual Optic Intraocular Lens |
Primary outcome
Distance corrected near visual acuity
Time frame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
1 secondary outcome
Best corrected distance visual acuity
Time frame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Monofocal Intraocular Lens and Synchrony® Dual Optic Intraocular Lens in people with Cataract, run by Abbott Medical Optics at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance corrected near visual acuity (time frame: 1 Mo, 4-6 Mo, 12 Mo, 24 Mo, & 36 Mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2013.