Evaluation the TECNIS IOL in Both Eyes VS the ReZoom IOL in One and TECNIS IOL in the Opposite

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute
ClinicalTrials.gov Identifier:
NCT01253239
First received: November 29, 2010
Last updated: July 18, 2016
Last verified: July 2016
  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

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

Resource links provided by NLM:


Further study details as provided by Bucci Laser Vision Institute:

Primary Outcome Measures:
  • Uncorrected visual acuity at distance and near [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients Satisfaction [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: November 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253239

Locations
United States, Pennsylvania
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Frank A. Bucci, Jr., M.D.
Investigators
Principal Investigator: Frank A Bucci, Jr., MD Bucci Laser Vision Institute
  More Information

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: July 18, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

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 July 21, 2016