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The Effect of a Blue Light Filtering IOL

NCT ID: NCT00571831

Last Updated: 2007-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-03-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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macula edema intraocular lens prospective randomized parallel clinical design

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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letter

a blue-filtering IOL an UV-filtering IOL

Group Type NO_INTERVENTION

intraocular lens implantation

Intervention Type PROCEDURE

Intraocular lens implantation

Interventions

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intraocular lens implantation

Intraocular lens implantation

Intervention Type PROCEDURE

Other Intervention Names

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a blue-filtering IOL (ENV-13, Menicon Co.Ltd, Japan) an UV-filtering IOL (ES-13, Menicon Co.Ltd, Japan)

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Showa University

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Ophthalmology, School of Medicine, Showa University

Principal Investigators

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Ryohei Koide, MD, PhD

Role: STUDY_DIRECTOR

Department of Ophthalmology, School of Medicine, Showa University

Locations

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Showa University Hospital

Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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showa-IRB-02503

Identifier Type: -

Identifier Source: secondary_id

Toshi-1

Identifier Type: -

Identifier Source: org_study_id