Influence of Blue Light Filtering Intraocular Lenses on Daytime Levels of Melatonin (BluMel)
April 20, 2009 updated by: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Influence of Blue Light Filtering Intra Ocular Lenses on Daytime Levels of Melatonin in Patients With Non-Exudative Age-Related Macular Degeneration
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
136
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vienna, Austria, 1030
- Rudolf Foundation Clinic, Department of Ophthalmology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 exclusion criteria:
- Study eye with exudative AMD
- Study eye with concomitant retinal or choroidal disorder other than AMD
- Study eye with significant keratopathies
- Fundus not visible
- Intake of medication known to affect melatonin secretion (within the last 12 hours): ß-blockers, calcium channel blockers, a-blockers, non-steroidal anti-inflammatory drugs, benzodiazepines, antidepressants, hypnotic drugs, antipsychotics, barbiturates, antiepileptic drugs, and melatonin
- Alcohol or caffeine consumption 6 hours before vein puncture
- Patients who are unwilling to adhere to visit examination schedules
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
White Alcon IOL
|
Implantation of white Alcon IOL
|
|
Active Comparator: 2
Yellow Alcon IOL
|
Implantation of yellow Alcon IOL
|
|
Active Comparator: 3
White Hoya IOL
|
Implantation of white Hoya IOL
|
|
Active Comparator: 4
Yellow Hoya IOL
|
Implantation of yellow Hoya IOL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Melatonin daytime levels in serum
Time Frame: 1, 6, 12, and 36 months postoperative
|
1, 6, 12, and 36 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of drusen, retinal thickness, pupil size, sleeping time
Time Frame: 1, 6, 12, and 36 months postoperative
|
1, 6, 12, and 36 months postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Katharina E. Schmid-Kubista, MD, LBI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
March 5, 2007
First Submitted That Met QC Criteria
March 5, 2007
First Posted (Estimate)
March 7, 2007
Study Record Updates
Last Update Posted (Estimate)
April 22, 2009
Last Update Submitted That Met QC Criteria
April 20, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBI-06-172-1006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.