Influence of Blue Light Filtering Intraocular Lenses on Daytime Levels of Melatonin (BluMel)

This study has been terminated.
(Because only a few patients follow the inclusion and exclusion criteria.)
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00444249
First received: March 5, 2007
Last updated: April 20, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention
Macular Degeneration
Procedure: White Alcon IOL
Procedure: Yellow Alcon IOL
Procedure: White Hoya IOL
Procedure: Yellow Hoya IOL

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Influence of Blue Light Filtering Intra Ocular Lenses on Daytime Levels of Melatonin in Patients With Non-Exudative Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • Melatonin daytime levels in serum [ Time Frame: 1, 6, 12, and 36 months postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of drusen, retinal thickness, pupil size, sleeping time [ Time Frame: 1, 6, 12, and 36 months postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 136
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
White Alcon IOL
Procedure: White Alcon IOL
Implantation of white Alcon IOL
Active Comparator: 2
Yellow Alcon IOL
Procedure: Yellow Alcon IOL
Implantation of yellow Alcon IOL
Active Comparator: 3
White Hoya IOL
Procedure: White Hoya IOL
Implantation of white Hoya IOL
Active Comparator: 4
Yellow Hoya IOL
Procedure: Yellow Hoya IOL
Implantation of yellow Hoya IOL

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444249

Locations
Austria
Rudolf Foundation Clinic, Department of Ophthalmology
Vienna, Austria, 1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Principal Investigator: Katharina E. Schmid-Kubista, MD LBI
  More Information

No publications provided

Responsible Party: Prof. Dr. Susanne Binder, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
ClinicalTrials.gov Identifier: NCT00444249     History of Changes
Other Study ID Numbers: LBI-06-172-1006
Study First Received: March 5, 2007
Last Updated: April 20, 2009
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
age-related macular degeneration
melatonin
blue-light filter

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Dipivefrin
Melatonin
Adrenergic Agents
Adrenergic Agonists
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014