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OpenTrials
Completed

NCT Number: NCT00571831

The Effect of a Blue Light Filtering IOL

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).

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Showa University Hospital

Tokyo, 142-8666, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraocular lens implantation

Procedure

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)

Primary outcomes

  1. To measure FA, VEP and OCT.

    Time frame: At 3 and 12 months after IOL implantation

Sponsors and collaborators

Lead sponsor

Showa University

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Dec 12, 2007
Registry last updated
Dec 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.