NCT01166971

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 8, 2011

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

July 19, 2010

Results QC Date

October 4, 2011

Last Update Submit

November 21, 2011

Conditions

Cataract

Keywords

presbyopiaintraocular lens

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

ReSTOR +3

EXPERIMENTAL

Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction

Device: ReSTOR +3

Tecnis MF

ACTIVE COMPARATOR

Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction

Device: Tecnis MF

Interventions

ReSTOR +3DEVICE

Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction

ReSTOR +3
Tecnis MFDEVICE

Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

Tecnis MF

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with bilateral cataracts
  • candidate for presbyopic lens

You may not qualify if:

  • \>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
  • pre-existing conditions that could skew the results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Eye Center of North Florida

Panama City, Florida, 32405, United States

Location

Carolina Eye Care Physicians

Charleston, South Carolina, 29414, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Results Point of Contact

Title
Director of Alcon Clinical
Organization
Alcon Research, Ltd.
medinfo@alconlabs.com
888.451.3937; 817.568.6725

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 21, 2010

Study Start

July 1, 2010

Primary Completion

March 1, 2011

Last Updated

November 24, 2011

Results First Posted

November 8, 2011

Record last verified: 2011-11

Locations

US(3)