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The Effect of a Blue Light Filtering IOL

S

Showa University

Status

Completed

Conditions

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

Treatments

Procedure: intraocular lens implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00571831
Toshi-1
showa-IRB-02503

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 1 patient group

letter
No Intervention group
Description:
a blue-filtering IOL an UV-filtering IOL
Treatment:
Procedure: intraocular lens implantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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