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The Effect of a Blue Light Filtering IOL

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

intraocular lens implantation

About this trial

This is an interventional prevention trial for to Compare the Effect of Two Types of IOLs focused on measuring macula edema, intraocular lens, prospective randomized parallel clinical design

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Showa University Hospital

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

letter

Arm Description

a blue-filtering IOL an UV-filtering IOL

Outcomes

Primary Outcome Measures

To measure FA, VEP and OCT.

Secondary Outcome Measures

Full Information

NCT ID

NCT00571831

First Posted

December 11, 2007

Last Updated

December 11, 2007

Sponsor

Showa University

1. Study Identification

Unique Protocol Identification Number

NCT00571831

Brief Title

The Effect of a Blue Light Filtering IOL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

February 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Showa University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

macula edema, intraocular lens, prospective randomized parallel clinical design

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

letter

Arm Type

No Intervention

Arm Description

a blue-filtering IOL an UV-filtering IOL

Intervention Type

Procedure

Intervention Name(s)

intraocular lens implantation

Other Intervention Name(s)

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

Intervention Description

Intraocular lens implantation

Primary Outcome Measure Information:

Title

To measure FA, VEP and OCT.

Time Frame

At 3 and 12 months after IOL implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryohei Koide, MD, PhD

Organizational Affiliation

Department of Ophthalmology, School of Medicine, Showa University

Official's Role

Study Director

Facility Information:

Facility Name

Showa University Hospital

City

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

12. IPD Sharing Statement

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The Effect of a Blue Light Filtering IOL

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