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The Effect of a Blue Light Filtering IOL

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00571831
First Posted: December 12, 2007
Last Update Posted: December 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Showa University
  Purpose
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 Intervention
to Compare the Effect of Two Types of IOLs on the Incidence of Cystoid Macular Edema After Cataract Surgery Procedure: intraocular lens implantation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Showa University:

Primary Outcome Measures:
  • To measure FA, VEP and OCT. [ Time Frame: At 3 and 12 months after IOL implantation ]

Enrollment: 50
Study Start Date: February 2003
Study Completion Date: March 2005
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571831


Locations
Japan
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
  More Information

Responsible Party: Toshihiko Ueda/Associate Professor, Dept. of Ophthalmology, School of Medicine, Showa University
ClinicalTrials.gov Identifier: NCT00571831     History of Changes
Other Study ID Numbers: Toshi-1
showa-IRB-02503
First Submitted: December 11, 2007
First Posted: December 12, 2007
Last Update Posted: December 12, 2007
Last Verified: December 2007

Keywords provided by Showa University:
macula edema
intraocular lens
prospective randomized parallel clinical design

Additional relevant MeSH terms:
Cataract
Macular Edema
Capsule Opacification
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases


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