The Effect of a Blue Light Filtering IOL

Not Applicable

Completed

• Conditions: on the Incidence of Cystoid Macular Edema; After Cataract Surgery; to Compare the Effect of Two Types of IOLs
• Interventions: Procedure: intraocular lens implantation

• Registration Number: NCT00571831
• Lead Sponsor: Showa University

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.

Study Timeline

• Study Start: 2003-02
• Study Completion: 2005-03
• Status Verified: 2007-12
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Last Update Submitted: 2007-12-11
• Study First Posted: 2007-12-12
• Last Update Posted: 2007-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
letter	intraocular lens implantation	a blue-filtering IOL an UV-filtering IOL

Primary Outcome Measures

Name	Time	Method
To measure FA, VEP and OCT.	At 3 and 12 months after IOL implantation

Trial Locations

Locations (1)

Showa University Hospital; 🇯🇵 Tokyo, Japan