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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253239
• Other study ID #: TECNIS-ReZoom-2010
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: July 18, 2016
• Start date: November 2010
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Bucci Laser Vision Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Years to 86 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
United States	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Frank A. Bucci, Jr., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected visual acuity at distance and near		Six months	No
Secondary	Patients Satisfaction		Six months	No