NCT00710996

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 29, 2010

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

9 months

First QC Date

July 3, 2008

Results QC Date

September 18, 2009

Last Update Submit

January 29, 2010

Conditions

Cataract

Keywords

AcrySof IQ IOL

Outcome Measures

Primary Outcomes (1)

  • Photostress Recovery Time in Seconds.

    The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.

    3 months

Study Arms (3)

AcrySof Natural Intraocular Lens

AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SN"

AcrySof clear intraocular lens

AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters "SA"

Phakic patients

Phakic patients - Age matched patients who have not had cataract surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients with existing bilateral IOLs of given type, age-matched patients with normal vision and no cataract surgery.

You may not qualify if:

  • Age related

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Call Alcon Call Center for Study Locations

Fort Worth, Texas, 76134, United States

Location

Related Publications (1)

  • Hammond BR, Bernstein B, Dong J. The Effect of the AcrySof natural lens on glare disability and photostress. Am J Ophthalmol. 2009 Aug;148(2):272-276.e2. doi: 10.1016/j.ajo.2009.03.014. Epub 2009 May 7.

    PMID: 19426959DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Rick Potvin
Organization
Alcon Research, Ltd.
Rick.Potvin@alconlabs.com
817-551-4815

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 8, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 2, 2010

Results First Posted

January 29, 2010

Record last verified: 2010-01

Locations

US(1)