Protocol Number: 07-CH-0169

Title:

Noninvasive Optical Imaging of the Effects of External Spectral Filters on Macular Autofluorescence in Pseudophakic Eyes

Number:

07-CH-0169

Summary:

This study will test a new method for preventing worsening of age-related macular degeneration (AMD) and for developing imaging methods to follow the very earliest microscopic changes in the disease. The macula is the part of the retina in the back of the eye that determines central vision. AMD can impair central vision, affecting a person's ability to read, drive, and carry out daily activities. Some studies suggest that cumulative exposure to sunlight increases the risk for progression of AMD to the late stage that is often characterized by poor central vision. This study will determine if wearing glasses with a yellow filter over one eye and a red-violet filter over the other eye when outdoors will decrease the rate of change of early-stage AMD in one or both eyes.

Patients early-stage AMD who have had cataract surgery in both eyes with implanted lenses may be eligible for this study.

Participants undergo the following procedures:

-Wear the filter glasses when outdoors between 10:00 a.m. and 4:00 p.m.

-Record the time of day and light environment when they use the glasses.

-Have an eye examination, pictures of the retina, and a medical history taken at the beginning of the study and at set intervals during the study.

The study lasts at least 12 months and may be extended for a longer period of time.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Recruitment has not started

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Autofluorescence Imaging

Early Age-Related Maculopathy

Photochemical Changes

Colored Sunglasses

Pseudophakes

Fundus Camera

Confocal Scanning Laser Ophthalmoscope

Molecular Imaging within Retina

Spectral Balance among Photochemical Processes

Noninvasive Autofluorescence Imaging

Age-Related Maculopathy (AMD)

Recruitment Keyword(s):

Age-Related Macular Degeneration

AMD

Age-Related Macular Changes

Early Age-Related Macular Changes

Condition(s):

Age-Related Macular Changes

Age-Related Macular Degeneration

Cataract and IOL Surgery

Retinal Photochemistry

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

None

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Klein R, Klein BE, Linton KL. Prevalence of age-related maculopathy. The Beaver Dam Eye Study. Ophthalmology. 1992 Jun;99(6):933-43.

Taylor HR, West S, Munoz B, Rosenthal FS, Bressler SB, Bressler NM. The long-term effects of visible light on the eye. Arch Ophthalmol. 1992 Jan;110(1):99-104.

Tomany SC, Cruickshanks KJ, Klein R, Klein BE, Knudtson MD. Sunlight and the 10-year incidence of age-related maculopathy: the Beaver Dam Eye Study. Arch Ophthalmol. 2004 May;122 (5):750-7. Erratum in: Arch Ophthalmol. 2005 Mar;123(3):362.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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