Effects of Sun Filters on Age-related Macular Degeneration in People With Lens Implants

NCT00487838 | Withdrawn

• 2 other identifiers: 07016907-CH-0169
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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....

Conditions

Age-Related Macular Changes; Age-Related Macular Degeneration; Cataract and IOL Surgery; Retinal Photochemistry

Keywords

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); Age-Related Macular Degeneration; AMD; Age-Related Macular Changes; Early Age-Related Macular Changes

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All eligible patients are invited to participate in this study.
• Patients will be local area residents who average greater than or equal to 2 hours outdoors daily, who are willing to follow the protocol of wearing our bicolor sunglasses whenever outdoors in daylight and to keep a log book of use and to return periodically to NIH for our noninvasive imaging studies.

You may not qualify if:

• Individuals with signs of more advanced age-related maculopathy in either eye such as identifiable regions of geographic atrophy or choroidal neovascularization.
• Individuals with prior eye disorders (other than uncomplicated cataract surgery and early age-related maculopathy).
• Individuals with diabetes mellitus, current chemotherapy, or other medicines or conditions that may affect our ability to perform accurate autofluorescence imaging or interfere with follow-up visits.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Related Publications (3)

• Klein R, Klein BE, Linton KL. Prevalence of age-related maculopathy. The Beaver Dam Eye Study. Ophthalmology. 1992 Jun;99(6):933-43. doi: 10.1016/s0161-6420(92)31871-8.

  PMID: 1630784 BACKGROUND

• 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. doi: 10.1001/archopht.1992.01080130101035.

  PMID: 1731731 BACKGROUND

• 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. doi: 10.1001/archopht.122.5.750.

  PMID: 15136324 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration; Cataract

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Lens Diseases

Study Officials

• Jack A Yanovski, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 16, 2007
• First Posted: June 19, 2007
• Study Start: June 14, 2007
• Study Completion: May 4, 2012
• Last Updated: July 2, 2017

Record last verified: 2012-05-04