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The Effect of a Blue Light Filtering IOL

Sponsor
Showa University (Other)
Overall Status
Completed
CT.gov ID
NCT00571831
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
24.9
Duration (Months)
2
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: intraocular lens implantation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery
Study Start Date :
Feb 1, 2003
Actual Study Completion Date :
Mar 1, 2005

Arms and Interventions

Arm Intervention/Treatment
No Intervention: letter

a blue-filtering IOL an UV-filtering IOL

Procedure: intraocular lens implantation
Intraocular lens implantation
Other Names:
  • a blue-filtering IOL (ENV-13, Menicon Co.Ltd, Japan)
  • an UV-filtering IOL (ES-13, Menicon Co.Ltd, Japan)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To measure FA, VEP and OCT. [At 3 and 12 months after IOL implantation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Showa University Hospital Tokyo Japan 142-8666

    Sponsors and Collaborators

    • Showa University

    Investigators

    • Study Director: Ryohei Koide, MD, PhD, Department of Ophthalmology, School of Medicine, Showa University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00571831
    Other Study ID Numbers:
    • Toshi-1
    • showa-IRB-02503
    First Posted:
    Dec 12, 2007
    Last Update Posted:
    Dec 12, 2007
    Last Verified:
    Dec 1, 2007
    Keywords provided by , ,
    macula edema
    intraocular lens
    prospective randomized parallel clinical design
    Additional relevant MeSH terms:
    Cataract
    Macular Edema
    Capsule Opacification

    Study Results

    No Results Posted as of Dec 12, 2007