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

NCT00444249 | Terminated

• 1 other identifier: LBI-06-172-1006
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

age-related macular degeneration; melatonin; blue-light filter

Outcome Measures

Primary Outcomes (1)

• Melatonin daytime levels in serum

  1, 6, 12, and 36 months postoperative

Secondary Outcomes (1)

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

  1, 6, 12, and 36 months postoperative

Study Arms (4)

1

ACTIVE COMPARATOR

White Alcon IOL

Procedure: White Alcon IOL

2

ACTIVE COMPARATOR

Yellow Alcon IOL

Procedure: Yellow Alcon IOL

3

ACTIVE COMPARATOR

White Hoya IOL

Procedure: White Hoya IOL

4

ACTIVE COMPARATOR

Yellow Hoya IOL

Procedure: Yellow Hoya IOL

Interventions

White Alcon IOL PROCEDURE

Implantation of white Alcon IOL

1

Yellow Alcon IOL PROCEDURE

Implantation of yellow Alcon IOL

2

White Hoya IOL PROCEDURE

Implantation of white Hoya IOL

3

Yellow Hoya IOL PROCEDURE

Implantation of yellow Hoya IOL

4

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery: lead

Study Sites (1)

Rudolf Foundation Clinic, Department of Ophthalmology

Vienna, Vienna, 1030, Austria

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Katharina E. Schmid-Kubista, MD

  LBI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 7, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 22, 2009

Record last verified: 2009-04

Locations

AU (1)