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Contralateral ReSTOR / Monofocal or Phakic Eye

Primary Purpose

Cataracts

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ReSTOR
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring AcrySof, ReSTOR, Multifocal, Intraocular Lens

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unilateral operable cataract
  • Candidate for presbyopic intraocular lens (IOL)

Exclusion Criteria:

  • Ocular comorbidities compromising primary outcome
  • Bilateral cataracts

Sites / Locations

  • Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Monofocal

Phakic

Arm Description

Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye

Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending

Outcomes

Primary Outcome Measures

Visual Acuity
Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures

Contrast Sensitivity
Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Patient Satisfaction
Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).
Spectacle Independence
The percentage of patients reporting spectacle independence (no longer needing to wear glasses).

Full Information

First Posted
August 7, 2008
Last Updated
March 19, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00731640
Brief Title
Contralateral ReSTOR / Monofocal or Phakic Eye
Official Title
Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

5. Study Description

Brief Summary
Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
AcrySof, ReSTOR, Multifocal, Intraocular Lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monofocal
Arm Type
Active Comparator
Arm Description
Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye
Arm Title
Phakic
Arm Type
Active Comparator
Arm Description
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Intervention Type
Device
Intervention Name(s)
ReSTOR
Intervention Description
AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Contrast Sensitivity
Description
Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Time Frame
6 Months
Title
Patient Satisfaction
Description
Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).
Time Frame
6 Months Postoperative
Title
Spectacle Independence
Description
The percentage of patients reporting spectacle independence (no longer needing to wear glasses).
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral operable cataract Candidate for presbyopic intraocular lens (IOL) Exclusion Criteria: Ocular comorbidities compromising primary outcome Bilateral cataracts
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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