search
Back to results

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

Primary Purpose

Macular Degeneration

Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
White Alcon IOL
Yellow Alcon IOL
White Hoya IOL
Yellow Hoya IOL
Sponsored by
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Macular Degeneration focused on measuring age-related macular degeneration, melatonin, blue-light filter

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rudolf Foundation Clinic, Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

White Alcon IOL

Yellow Alcon IOL

White Hoya IOL

Yellow Hoya IOL

Outcomes

Primary Outcome Measures

Melatonin daytime levels in serum

Secondary Outcome Measures

Number of drusen, retinal thickness, pupil size, sleeping time

Full Information

First Posted
March 5, 2007
Last Updated
April 20, 2009
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
search

1. Study Identification

Unique Protocol Identification Number
NCT00444249
Brief Title
Influence of Blue Light Filtering Intraocular Lenses on Daytime Levels of Melatonin
Acronym
BluMel
Official Title
Influence of Blue Light Filtering Intra Ocular Lenses on Daytime Levels of Melatonin in Patients With Non-Exudative Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
Because only a few patients follow the inclusion and exclusion criteria.
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
age-related macular degeneration, melatonin, blue-light filter

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
White Alcon IOL
Arm Title
2
Arm Type
Active Comparator
Arm Description
Yellow Alcon IOL
Arm Title
3
Arm Type
Active Comparator
Arm Description
White Hoya IOL
Arm Title
4
Arm Type
Active Comparator
Arm Description
Yellow Hoya IOL
Intervention Type
Procedure
Intervention Name(s)
White Alcon IOL
Intervention Description
Implantation of white Alcon IOL
Intervention Type
Procedure
Intervention Name(s)
Yellow Alcon IOL
Intervention Description
Implantation of yellow Alcon IOL
Intervention Type
Procedure
Intervention Name(s)
White Hoya IOL
Intervention Description
Implantation of white Hoya IOL
Intervention Type
Procedure
Intervention Name(s)
Yellow Hoya IOL
Intervention Description
Implantation of yellow Hoya IOL
Primary Outcome Measure Information:
Title
Melatonin daytime levels in serum
Time Frame
1, 6, 12, and 36 months postoperative
Secondary Outcome Measure Information:
Title
Number of drusen, retinal thickness, pupil size, sleeping time
Time Frame
1, 6, 12, and 36 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharina E. Schmid-Kubista, MD
Organizational Affiliation
LBI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rudolf Foundation Clinic, Department of Ophthalmology
City
Vienna
ZIP/Postal Code
1030
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs