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Presbyopia-Correcting Intraocular Lenses (IOLs)

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ReSTOR +3
Crystalens HD
Crystalens AO
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring ReSTOR +3

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosed with bilateral cataracts
  • candidate for presbyopic lens

Exclusion Criteria:

  • > 1 Diopter preoperative astigmatism by Keratometry readings
  • pre-existing conditions that could skew the results

Sites / Locations

  • Contact Alcon Call Center For Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

ReSTOR +3

Crystalens HD

Crystalens AO

Arm Description

Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)

Bilateral implantation of Crystalens HD Intraocular Lens (IOL)

Bilateral implantation of Crystalens AO Intraocular Lens (IOL)

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity
Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2009
Last Updated
July 13, 2011
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00963560
Brief Title
Presbyopia-Correcting Intraocular Lenses (IOLs)
Official Title
A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
ReSTOR +3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReSTOR +3
Arm Type
Experimental
Arm Description
Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
Arm Title
Crystalens HD
Arm Type
Active Comparator
Arm Description
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
Arm Title
Crystalens AO
Arm Type
Active Comparator
Arm Description
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
Intervention Type
Device
Intervention Name(s)
ReSTOR +3
Intervention Description
Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.
Intervention Type
Device
Intervention Name(s)
Crystalens HD
Intervention Description
Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.
Intervention Type
Device
Intervention Name(s)
Crystalens AO
Intervention Description
Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.
Time Frame
6 Months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with bilateral cataracts candidate for presbyopic lens Exclusion Criteria: > 1 Diopter preoperative astigmatism by Keratometry readings pre-existing conditions that could skew the results
Facility Information:
Facility Name
Contact 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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Presbyopia-Correcting Intraocular Lenses (IOLs)

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