Status:
TERMINATED
Influence of Blue Light Filtering Intraocular Lenses on Daytime Levels of Melatonin
Lead Sponsor:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Conditions:
Macular Degeneration
Eligibility:
All Genders
60+ years
Phase:
NA
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-ligh...
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 le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00444249
Start Date
March 1 2007
End Date
August 1 2008
Last Update
April 22 2009
Active Locations (1)
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1
Rudolf Foundation Clinic, Department of Ophthalmology
Vienna, Vienna, Austria, 1030