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Clinical Trial 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).


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00571831
Study type Interventional
Source Showa University
Contact
Status Completed
Phase N/A
Start date February 2003
Completion date March 2005