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NCT01166971 Clinical Trial

A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

Cataract Clinical Trial

Official title:
A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01166971
Other study ID # M09-050
Secondary ID
Status Completed
Phase Phase 4
First received July 19, 2010
Last updated November 21, 2011
Start date July 2010

Study information
Verified date November 2011
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- diagnosed with bilateral cataracts

- candidate for presbyopic lens

Exclusion Criteria:

- >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings

- pre-existing conditions that could skew the results

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• ReSTOR +3
Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction
• Tecnis MF
Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

Locations
Country Name City State
United States Carolina Eye Care Physicians Charleston South Carolina
United States Whitsett Vision Group Houston Texas
United States The Eye Center of North Florida Panama City Florida

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Defocus Curve A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". 3 months after surgery No
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