The Effect of a Blue Light Filtering IOL
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|ClinicalTrials.gov Identifier: NCT00571831|
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : December 12, 2007
|Condition or disease||Intervention/treatment||Phase|
|to Compare the Effect of Two Types of IOLs on the Incidence of Cystoid Macular Edema After Cataract Surgery||Procedure: intraocular lens implantation||Not Applicable|
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)
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery|
|Study Start Date :||February 2003|
|Actual Study Completion Date :||March 2005|
No Intervention: letter
a blue-filtering IOL an UV-filtering IOL
Procedure: intraocular lens implantation
Intraocular lens implantation
- To measure FA, VEP and OCT. [ Time Frame: At 3 and 12 months after IOL implantation ]
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
|Showa University Hospital|
|Tokyo, Japan, 142-8666|
|Study Director:||Ryohei Koide, MD, PhD||Department of Ophthalmology, School of Medicine, Showa University|