Expired Study
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Fort Worth, Texas 76134


Purpose:

To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment levels.


Criteria:

Inclusion Criteria: - Patients with existing bilateral IOLs of given type, age-matched patients with normal vision and no cataract surgery. Exclusion Criteria: - Age related


Study is Available At:


Original ID:

M07-023


NCT ID:

NCT00710996


Secondary ID:


Study Acronym:


Brief Title:

Blue Light Intraocular Lenses (IOLs) and Photostress


Official Title:

Blue Light Intraocular Lenses (IOLs) and Photostress


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alcon Research


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: C


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

58


Enrollment Type:

Actual


Study Dates

Start Date:January 2008
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:October 2008
Primary Completion Type:Actual
Verification Date:January 2010
Last Changed Date:January 29, 2010
First Received Date:July 3, 2008
First Results Date:September 18, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Photostress Recovery Time in Seconds.
Time Frame:3 months
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:AcrySof Natural Intraocular Lens
Description:AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN"
Study Arm Type:Other
Arm Name:AcrySof clear intraocular lens
Description:AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA"
Study Arm Type:Other
Arm Name:Phakic patients
Description:Phakic patients - Age matched patients who have not had cataract surgery

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Alcon Research

Samples and Retentions

Study Population: Patients with existing bilateral Intraocular Lenses (IOLs) of given type, age-matched patients with normal vision and no cataract surgery.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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