Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months PreviouslyPhase 4NCT01279122
Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses
A Phase 4 study testing Nanoflex IOL in people with Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously, run by Innovative Medical at 1 site in United States.
Trial summary
The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously
- What is being tested?
- Nanoflex IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients at least 18 years of age.
- Patients who have bilateral NanoFlex implantation at least 3 months previously.
- No significant ocular pathology causing DCVA to be less than 20/25 or causing significant visual loss.
- DCVA of 20/25 or better in both eyes.
- Spherical equivalent in the dominant eye to be +/-.50 or less and in the non-dominant eye to be between-1.00 and -1.87.
- Uncorrected VA in dominant eye 20/25 or better.
Who cannot join
- History of ocular trauma or prior ocular surgery (minor ocular trauma is allowed such as small superficial corneal scar not effecting vision; some prior ocular surgery is allowable so long as it has not impacted visual acuity.
- Amblyopia or strabismus, significant visual field loss, or posterior capsular opacifcation.
- Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kenneth Lipstock
Richmond, Virginia
Annie Christensen, 951-653-5566, a.christensen@imedsonline.com
About this study
The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye.
- Being tested
- Nanoflex IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoflex IOLDevice
Patients who were implanted with the Nanoflex IOL
| Study group | Role | What they receive |
|---|---|---|
| Nanoflex IOL | No intervention | Not described Receives: Device: Nanoflex IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Near Visual Acuity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months PreviouslyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279122
- Sponsor's protocol ID
- STARR2010-NF-IOL
- Status last verified
- Feb 2011
- First submitted
- 14 Jan 2011
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses
- ClinicalTrials.gov ID
- NCT01279122
- Acronym / sponsor ID
- STARR2010-NF-IOL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 19 Jan 2011 (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 this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nanoflex IOL | No intervention | Device: Nanoflex IOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients at least 18 years of age.
- Patients who have bilateral NanoFlex implantation at least 3 months previously.
- No significant ocular pathology causing DCVA to be less than 20/25 or causing significant visual loss.
- DCVA of 20/25 or better in both eyes.
- Spherical equivalent in the dominant eye to be +/-.50 or less and in the non-dominant eye to be between-1.00 and -1.87.
Key exclusion criteria (3 listed)
- History of ocular trauma or prior ocular surgery (minor ocular trauma is allowed such as small superficial corneal scar not effecting vision; some prior ocular surgery is allowable so long as it has not impacted visual acuity.
- Amblyopia or strabismus, significant visual field loss, or posterior capsular opacifcation.
- Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.).
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 |
|---|---|---|
| Nanoflex IOLPatients who were implanted with the Nanoflex IOL | Device | Nanoflex IOL |
Primary outcome
Uncorrected Near Visual Acuity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nanoflex IOL in people with Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously, run by Innovative Medical at 1 site 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie Christensen (951-653-5566, a.christensen@imedsonline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Near Visual Acuity (time frame: 1 year). 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 17 Feb 2011.