The Effect of a Blue Light Filtering IOL

After Cataract Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571831
• Other study ID #: Toshi-1
• Secondary ID: showa-IRB-02503
• Status: Completed
• Phase: N/A
• First received: December 11, 2007
• Last updated: December 11, 2007
• Start date: February 2003
• Est. completion date: March 2005

Study information

• Verified date: December 2007
• Source: Showa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Procedure:
• intraocular lens implantation
Intraocular lens implantation

Locations

Country	Name	City	State
Japan	Showa University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Showa University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure FA, VEP and OCT.		At 3 and 12 months after IOL implantation	Yes