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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Cataract Edema

U.S. FDA Resources

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
No Intervention: letter a blue-filtering IOL an UV-filtering IOL	Procedure: intraocular lens implantation Intraocular lens implantation Other Names: a blue-filtering IOL (ENV-13, Menicon Co.Ltd, Japan) an UV-filtering IOL (ES-13, Menicon Co.Ltd, Japan)

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

No publications provided

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

Keywords provided by Showa University:

macula edema
intraocular lens
prospective randomized parallel clinical design

Additional relevant MeSH terms:

Edema
Macular Edema
Cataract
Signs and Symptoms
Macular Degeneration

Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on February 12, 2012