Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342251
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Investigating Age-Related Macular Degeneration
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Age-Related Macular Degeneration A Genetic Epidemiology Study in the Amish
Status:
COMPLETED
Status Verified Date:
2012-04-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Age-related macular degeneration ARMD affects older Americans and can lead to irreversible blindness Although the cause if ARMD is unclear it appears to be a condition that is affected by both genetic and environmental influences
The purpose of this study is to examine an Amish community to investigate genetic factors in the development of ARMD
Study participants will be 1000 members ages 50 and older of the Old Order Amish community in Lancaster and Franklin counties in Pennsylvania Each will undergo a 30-minute dilated eye exam during which an ophthalmologist or optometrist will take digital images of the macula and optic disc Depending on the results of their eye exam participants may be asked to give a blood sample as well They will also complete a brief questionnaire about personal exposure related to occupation sunlight and smoking
The purpose of this study is to examine an Amish community to investigate genetic factors in the development of ARMD
Study participants will be 1000 members ages 50 and older of the Old Order Amish community in Lancaster and Franklin counties in Pennsylvania Each will undergo a 30-minute dilated eye exam during which an ophthalmologist or optometrist will take digital images of the macula and optic disc Depending on the results of their eye exam participants may be asked to give a blood sample as well They will also complete a brief questionnaire about personal exposure related to occupation sunlight and smoking
Detailed Description:
Age-related macular degeneration AMD is a leading cause of visual impairment in the United States Available evidence suggests that AMD is a complex disorder with a significant genetic component as well as potential environmental influences In this study we propose to examine 3000 members ages 50 and older of the Old Order Amish community in the Lancaster and Franklin counties area in Pennsylvania We plan to detail the epidemiology of AMD in this population isolate in attempt to elucidate genetic factors which may confer susceptibility and predispose some Amish individuals and their families to develop AMD All study participants agreeing to enroll and providing informed consent will undergo a complete dilated eye examination during which digital stereo images of the macula and optic disc regions will be acquired Study participants will also be asked to complete a brief questionnaire inquiring about personal exposures related to occupation sunlight and smoking AMD will be determined by an independent reading of the digital fundus photographs by the University of Wisconsin Fundus Photography Reading Center according to the AREDS AMD classification scheme We will employ standard statistical genetics methods of parametric and non-parametric linkage analysis association analysis and transmission disequilibrium tests with allowances for environmental ie non-genetic factors to determine if we can identify any candidate regions or candidate genes that predispose Amish individuals to an increased risk of AMD Ultimately we hope to follow up any regions that show suggestive evidence of linkage on the genome-wide scan with fine mapping in those regions leading to eventual cloning and sequencing of a gene or genes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-EI-N235 | None | None | None |