Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444249
Status:
TERMINATED
Last Update Posted:
2009-04-22
First Post:
2007-03-05
Brief Title:
Influence of Blue Light Filtering Intraocular Lenses on Daytime Levels of Melatonin
Sponsor:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Organization:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study Overview
Official Title:
Influence of Blue Light Filtering Intra Ocular Lenses on Daytime Levels of Melatonin in Patients With Non-Exudative Age-Related Macular Degeneration
Status:
TERMINATED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Because only a few patients follow the inclusion and exclusion criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BluMel
Brief Summary:
The blue light hazard has been reported to cause retinal damage oxidative stress particularly to the central fovea due to its energetic shorter wavelength visible photons which is why blue-light filtering intraocular lenses have been developed for cataract surgery The hormone melatonin has been reported to possess an efficient antioxidant capacity Light information from the eye reaches the suprachiasmatic nuclei and inhibits melatonin secretion Since melatonin is suppressed by light we have a day-night rhythmicity with increased levels at night Melatonin suppression is wavelength-dependent with a peak sensitivity in the 446-477 nm blue light portion of the visible spectrum The crystalline lens blocks most UV between 300 and 400 nm The density of the lens increases with aging causing an alteration in the spectral absorption The greatest increase in absorption occurs at the short wavelength end of the spectrum around 400-470 nm Age-related pupillary miosis and crystalline lens yellowing limit the blue light reaching the retina This reduces the older adults effective retinal light exposure to one tenth that of younger people It has been shown that insomnia and depression decrease after cataract surgery and patients returned to youthful levels of melatonin Since melatonin acts as an antioxidant and more blue light filtering intra ocular lenses are implanted and thought to reduce photochemical damage in the macula it would be interesting to show the positive influence of those blue light filtering intraocular lenses on daytime levels of melatonin in age-related macular degeneration patients
Detailed Description:
Patients with non-exudative age-related macular degeneration which are planned for cataract surgery will be randomized into one of four groups Group I and II are blue light filtering intraocular lenses and group III and IV are white lenses Group I and III are lenses form Alcon group II and IV are lenses form Hoya The following examinations will be performed before 1 month 6 months 1 year and 2 years after surgery vein puncture for melatonin analysis visual acuity complete slit lamp analysis including intraocular pressure pupil size measurement and questionnaire about sleeping time and sleeping quality At the follow-up visits the following examinations will also be performed autofluorescein imaging infrared imaging and optical coherence tomography imaging Vein puncture will be performed between 8 and 10 am and has to be performed at the same time for the same patient Pupils are not allowed to be dilated by the time of vein puncture and pupil size measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None