Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Innovative Medical.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Innovative Medical
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01279122
First received: January 14, 2011
Last updated: February 16, 2011
Last verified: February 2011
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Purpose
The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye.
| Condition | Intervention | Phase |
|---|---|---|
|
Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously |
Device: Nanoflex IOL |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses |
Further study details as provided by Innovative Medical:
Primary Outcome Measures:
- Uncorrected Near Visual Acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Nanoflex IOL |
Device: Nanoflex IOL
Patients who were implanted with the Nanoflex IOL
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279122
Contacts
| Contact: Annie Christensen | 951-653-5566 | a.christensen@imedsonline.com |
Locations
| United States, Virginia | |
| Kenneth Lipstock | Recruiting |
| Richmond, Virginia, United States | |
| Contact: Annie Christensen 951-653-5566 a.christensen@imedsonline.com | |
Sponsors and Collaborators
Innovative Medical
More Information
No publications provided
| Responsible Party: | Annie Christensen, IMEDS |
| ClinicalTrials.gov Identifier: | NCT01279122 History of Changes |
| Other Study ID Numbers: | STARR2010-NF-IOL |
| Study First Received: | January 14, 2011 |
| Last Updated: | February 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013