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Influence of Blue Light Filtering Intraocular Lenses on Daytime Levels of Melatonin

Influence of Blue Light Filtering Intra Ocular Lenses on Daytime Levels of Melatonin in Patients With Non-Exudative Age-Related Macular Degeneration

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00444249
Acronym
BluMel
Enrollment
136
Registered
2007-03-07
Start date
2007-03-31
Completion date
2008-08-31
Last updated
2009-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

age-related macular degeneration, melatonin, blue-light filter

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 a.m. 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.

Interventions

PROCEDUREWhite Alcon IOL

Implantation of white Alcon IOL

PROCEDUREYellow Alcon IOL

Implantation of yellow Alcon IOL

PROCEDUREWhite Hoya IOL

Implantation of white Hoya IOL

PROCEDUREYellow Hoya IOL

Implantation of yellow Hoya IOL

Sponsors

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients are included if they meet all of the following inclusion criteria: * Cataract on one or both eyes * Study eye with non-exudative AMD AREDS I - III * Men or women aged between 60 - 99 years * Patient planned for cataract surgery and in need of an intraocular lens

Exclusion criteria

Patients are excluded if they meet one or more of the following

Design outcomes

Primary

MeasureTime frame
Melatonin daytime levels in serum1, 6, 12, and 36 months postoperative

Secondary

MeasureTime frame
Number of drusen, retinal thickness, pupil size, sleeping time1, 6, 12, and 36 months postoperative

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026