Official Title: “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 Type: Interventional

Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

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.

Intervention(s) in this Clinical Trial

• Procedure: White Alcon IOL
  • Implantation of white Alcon IOL
• Procedure: Yellow Alcon IOL
  • Implantation of yellow Alcon IOL
• Procedure: White Hoya IOL
  • Implantation of white Hoya IOL
• Procedure: Yellow Hoya IOL
  • Implantation of yellow Hoya IOL

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • White Alcon IOL
• Active Comparator: 2
  • Yellow Alcon IOL
• Active Comparator: 3
  • White Hoya IOL
• Active Comparator: 4
  • Yellow Hoya IOL

Primary Measures

• Melatonin daytime levels in serum
  • Time Frame: 1, 6, 12, and 36 months postoperative
    Safety Issue?: No

Secondary Measures

• Number of drusen, retinal thickness, pupil size, sleeping time
  • Time Frame: 1, 6, 12, and 36 months postoperative
    Safety Issue?: 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 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Overall Clinical Trial Officials and Contacts

Katharina E. Schmid-Kubista, MD Principal Investigator LBI  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00444249

Study ID Number: LBI-06-172-1006

ClinicalTrials.gov Identifier: NCT00444249

Health Authority: Austria: Ethikkommission