Evaluation the TECNIS IOL in Both Eyes VS the ReZoom IOL in One and TECNIS IOL in the Opposite
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Purpose
The purpose of this study is to evaluate the visual performance of two cohorts of patients who received multifocal intraocular lenses following cataract and clear lens extraction surgeries. Comparing visual outcomes of patients who were implanted with TECNIS Multifocal IOLs in both eyes versus patients implanted with TECNIS Multifocal in one eye and ReZoom Multifocal IOL in the opposite eye.
| Condition |
|---|
|
Cataract Extraction |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | A Retrospective Evaluation Comparing Post Operative Visual Outcomes in Patients Implanted With the TECNIS IOL in Both Eyes Versus the ReZoom IOL in One Eye and TECNIS IOL in the Opposite Eye |
- Uncorrected visual acuity at distance and near [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Patients Satisfaction [ Time Frame: Six months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
TECNIS/ReZoom
Patients who received a TECNIS multifocal IOL in one eye and a ReZoom multifocal IOL in the opposite eye.
|
|
TECNIS/TECNIS
Patients who received TECNIS multifocal IOLs in both eyes
|
Detailed Description:
Stable post operative cataract and clear lens extraction patients who have been implanted with either the TECNIS Multifocal IOL in both eyes or TECNIS Multifocal IOL in one eye and theReZoom Multifocal IOL in the opposite eye.
Study Design-A retrospective chart review to collect visual outcomes to determine lens performance. Patient satisfaction questionnaire will be administered to determine spectacle independence.
Eligibility| Ages Eligible for Study: | 42 Years to 86 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Stable post operative cataract and clear lens extraction patients who have been implanted with either the TECNIS multifocal IOLs in both eyes or TECNIS multifocal IOL in one eye and the ReZoom in the opposite eye
Inclusion Criteria:
- Patients who have undergone surgery and received either the TECNIS Multifocal Intraocular lens in one eye and the ReZoom Multifocal Intraocular lens in the other will be evaluated. Males and Females with ages ranging from 42 years to 86 years old.
Exclusion Criteria:
- Patients who have subsequently developed any visual limiting problems (e.g. corneal, retinal, infection) which could potentially limit their post operative visual potential.
Contacts and Locations| United States, Pennsylvania | |
| Bucci Laser Vision Institute | Recruiting |
| Wilkes-Barre, Pennsylvania, United States, 18702 | |
| Contact: Ruth Evans 570-825-5949 Ruth@buccivision.com | |
| Contact: Barbara Michalek 570-825-5949 Barb@buccivision.com | |
| Principal Investigator: Frank A. Bucci, Jr., MD | |
| Principal Investigator: | Frank A Bucci, Jr., MD | Bucci Laser Vision Institute |
More Information
No publications provided
| Responsible Party: | Frank A. Bucci, Jr., M.D., Principal Investigator, Bucci Laser Vision Institute |
| ClinicalTrials.gov Identifier: | NCT01253239 History of Changes |
| Other Study ID Numbers: | TECNIS-ReZoom-2010 |
| Study First Received: | November 29, 2010 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Bucci Laser Vision Institute:
|
Visual outcomes Patient satisfaction |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013