Age-Related Macular ChangesNCT00487838
Effects of Sun Filters on Age-related Macular Degeneration in People With Lens Implants
An observational study of Age-Related Macular Changes and Age-Related Macular Degeneration, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Age-Related Macular Changes, Age-Related Macular Degeneration, Cataract and IOL Surgery
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2007to 4 May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Noninvasive Optical Imaging of the Effects of External Spectral Filters on Macular Autofluorescence in Pseudophakic Eyes
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.
Read more
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....
Read the detailed description
Accumulation of the photoproduct N-retinylidene-n-retinylethaholamine (A2E) within the retina may be associated with the early age-related macular degeneration (AMD). Our biophysical model of retinal photochemistries predicts that as the lens yellows with age a spectral imbalance of the light reaching the retina causes steady-state A2E levels to rise in the RPE, which induces increasing RPE stress leading to AMD progression. If correct, this rise in A2E levels and the initial injury could be prevented by appropriately chosen spectral filtering (e.g., colored sunglasses). Autofluorescence imaging of the retina currently allows noninvasive mapping of total accumulated lipofuscin fluorophores within the macular retinal pigment epithelium (RPE) but not A2E or its precursor alone. By adding new sets of excitation and emission filters to existing fundus cameras and confocal scanning laser ophthalmoscopes, we propose to map individually both A2E and its precursor A2PEH2 or their fractional contributions to the total retinal fluorescence. By following A2E fluorescence in both eyes in subjects following bilateral cataract surgery and intra-ocular lens [IOL] implantation with early symmetric age-related maculopathy who wear our bicolored sunglasses whenever outdoors in the daylight, we propose to test this hypothesis while efficiently controlling for hidden genetic, physiological, and environmental confounding variables between subjects. This pilot protocol seeks to optimize recruitment of suitable subjects and the reproducibility of our spectral imaging and noninvasive analysis of A2E and A2PEH2 levels in the normal and microscopically abnormal regions of the macula. The data from this pilot study will be used to design a clinical study to test our hypothesis.
- 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
- Medical subject headings
- Macular Degeneration, Cataract
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study start14 Jun 2007
- Study completion4 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jack A Yanovski, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487838
- Sponsor's protocol ID
- 070169
- Other IDs
- 07-CH-0169
- Status last verified
- 4 May 2012
- First submitted
- 16 Jun 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 1630784Taylor 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.
PubMed 1731731Tomany 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.
PubMed 15136324
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Optical Imaging of the Effects of External Spectral Filters on Macular Autofluorescence in Pseudophakic Eyes
- ClinicalTrials.gov ID
- NCT00487838
- Acronym / sponsor ID
- 070169
- 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
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 14 Jun 2007
- Study completion
- 4 May 2012
- First posted
- 19 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
Accumulation of the photoproduct N-retinylidene-n-retinylethaholamine (A2E) within the retina may be associated with the early age-related macular degeneration (AMD). Our biophysical model of retinal photochemistries predicts that as the lens yellows with age a spectral imbalance of the light reaching the retina causes steady-state A2E levels to rise in the RPE, which induces increasing RPE stress leading to AMD progression. If correct, this rise in A2E levels and the initial injury could be prevented by appropriately chosen spectral filtering (e.g., colored sunglasses). Autofluorescence imaging of the retina currently allows noninvasive mapping of total accumulated lipofuscin fluorophores within the macular retinal pigment epithelium (RPE) but not A2E or its precursor alone. By adding new sets of excitation and emission filters to existing fundus cameras and confocal scanning laser ophthalmoscopes, we propose to map individually both A2E and its precursor A2PEH2 or their fractional contributions to the total retinal fluorescence. By following A2E fluorescence in both eyes in subjects following bilateral cataract surgery and intra-ocular lens [IOL] implantation with early symmetric age-related maculopathy who wear our bicolored sunglasses whenever outdoors in the daylight, we propose to test this hypothesis while efficiently controlling for hidden genetic, physiological, and environmental confounding variables between subjects. This pilot protocol seeks to optimize recruitment of suitable subjects and the reproducibility of our spectral imaging and noninvasive analysis of A2E and A2PEH2 levels in the normal and microscopically abnormal regions of the macula. The data from this pilot study will be used to design a clinical study to test our hypothesis.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 1630784Klein 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.
- Background: PubMed 1731731Taylor 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.
- Background: PubMed 15136324Tomany 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack A Yanovski, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Changes and Age-Related Macular Degeneration, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00487838, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.