The Effect of a Blue Light Filtering IOL - Full Text View

Purpose

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).

Condition	Intervention
to Compare the Effect of Two Types of IOLs on the Incidence of Cystoid Macular Edema After Cataract Surgery	Procedure: intraocular lens implantation

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Cataract Edema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Showa University:

Primary Outcome Measures:

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

Enrollment:	50
Study Start Date:	February 2003
Study Completion Date:	March 2005

Arms	Assigned Interventions
letter: No Intervention a blue-filtering IOL an UV-filtering IOL	Procedure: intraocular lens implantation Intraocular lens implantation

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.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571831

Locations


Japan
	Showa University Hospital
	Tokyo, Japan, 142-8666

Sponsors and Collaborators

Showa University

Investigators


Study Director:	Ryohei Koide, MD, PhD	Department of Ophthalmology, School of Medicine, Showa University

More Information

Responsible Party:	Dept. of Ophthalmology, School of Medicine, Showa University ( Toshihiko Ueda/Associate Professor )
Study ID Numbers:	Toshi-1, showa-IRB-02503
First Received:	December 11, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00571831
Health Authority:	Japan: Institutional Review Board

Keywords provided by Showa University:

macula edema

intraocular lens

prospective randomized parallel clinical design

Study placed in the following topic categories:

Macular Edema

Eye Diseases

Cataract

Retinal Degeneration

Macular Degeneration

Edema

Lens Diseases

Retinal Diseases

Retinal degeneration

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Showa University
Information provided by:	Showa University
ClinicalTrials.gov Identifier:	NCT00571831