The Effect of a Blue Light Filtering IOL | NCT00571831

Studies
The Effect of a Blue Light Filtering IOL

NCT00571831

Sponsor

Showa University

Status

Completed

Last Update Posted

Dec 12, 2007Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

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

Interventions

intraocular lens implantation

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
showa-IRB-02503

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Not provided

Completion Date

Mar 2005Actual

First Submitted Date

Dec 11, 2007

First Submission Date that Met QC Criteria

Dec 11, 2007

First Posted Date

Dec 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2007

Last Update Posted Date

Dec 12, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
letter	No Intervention	a blue-filtering IOL an UV-filtering IOL	Procedure: intraocular lens implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intraocular lens implantation	Procedure	Intraocular lens implantation	letter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To measure FA, VEP and OCT.		At 3 and 12 months after IOL implantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ryohei Koide, MD, PhD	Department of Ophthalmology, School of Medicine, Showa University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Showa University Hospital		Tokyo	Tokyo	142-8666	Japan

Intervention Browse Module

MeSH Terms

ID	Term
D019654	Lens Implantation, Intraocular

Ancestor Terms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

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