The Effect of a Blue Light Filtering IOL - Tabular View

Tracking Information

First Received Date ^ICMJE

December 11, 2007

Last Updated Date

December 11, 2007

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To measure FA, VEP and OCT. [ Time Frame: At 3 and 12 months after IOL implantation ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Effect of a Blue Light Filtering IOL

Official Title ^ICMJE

The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery

Brief Summary

To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL).

Detailed Description

The following parameters were measured for evaluation of blood retinal barrier disruption.

the incidence of macular leakage by fluorescence angiography (FA)
the mean fluorescein concentration in the vitreous by fluorophotometry (VFP)
the thickness of the macula by optical coherence tomography (OCT)

Results

the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12 months) in the blue-filtering IOL group (P<0.05), and was significantly lower compared with the UV-filtering IOL group at 12 months.
the VFP significantly decreased in both group from 3 to 12 months.
the OCT decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering IOL group.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

to Compare the Effect of Two Types of IOLs
on the Incidence of Cystoid Macular Edema
After Cataract Surgery

Intervention ^ICMJE

Procedure: intraocular lens implantation

Study Arms / Comparison Groups

No Intervention: a blue-filtering IOL an UV-filtering IOL

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

cataract patients
All eligible for intraocular lens implantation

Exclusion Criteria:

Patients had undergone an intraocular operation
Patients had hypertensive retinopathy
Patients had diabetic retinopathy
Patients had ange-related macular degeneration
no observable fundus
The cataract operation was more than 30 minutes in duration

Gender

Both

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00571831

Responsible Party

Toshihiko Ueda/Associate Professor, Dept. of Ophthalmology, School of Medicine, Showa University

Study ID Numbers ^ICMJE

Toshi-1, showa-IRB-02503

Study Sponsor ^ICMJE

Showa University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ryohei Koide, MD, PhD

Department of Ophthalmology, School of Medicine, Showa University

Information Provided By

Showa University

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP