The Effect of a Blue Light Filtering IOL

This study has been completed.
Sponsor:
Information provided by:
Showa University
ClinicalTrials.gov Identifier:
NCT00571831
First received: December 11, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 11, 2007
Last Updated: December 11, 2007
Health Authority: Japan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 01, 2014