Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078299
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-02-20
Brief Title:
Evaluation of the Age-Related Eye Disease Study AREDS Clinical Lens Grading System
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of the Age-Related Eye Disease Study AREDS Clinical Lens Grading System
Status:
COMPLETED
Status Verified Date:
2005-04
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:
This study will evaluate a system developed to grade the severity of age-related cataract a common cause of vision loss in older adults Cataract research requires methods to simply and accurately determine the type and severity of cataracts in order to develop new possibly non-surgical treatments
Patients 50 years of age and older with one of the three major age-related cataract types nuclear cortical and posterior subcapsular may be eligible for this study Participants will be recruited from among patients enrolled in other National Eye Institute protocols
Participants will have their eyes examined independently by two ophthalmologists with a biomicroscope a magnifying device routinely used during eye examinations The doctors will use the new grading system to record if a cataract is present and if so how severe it is The examination includes measurement of visual acuity vision chart test and examination of the lens retina pupils and eye movements Photographs of the eye will be taken using a special camera that flashes a bright light in the eye
Patients 50 years of age and older with one of the three major age-related cataract types nuclear cortical and posterior subcapsular may be eligible for this study Participants will be recruited from among patients enrolled in other National Eye Institute protocols
Participants will have their eyes examined independently by two ophthalmologists with a biomicroscope a magnifying device routinely used during eye examinations The doctors will use the new grading system to record if a cataract is present and if so how severe it is The examination includes measurement of visual acuity vision chart test and examination of the lens retina pupils and eye movements Photographs of the eye will be taken using a special camera that flashes a bright light in the eye
Detailed Description:
Standardized lens photography with centralized grading of photographs has been used in clinical trials and epidemiologic studies of cataract While photographic grading systems have been shown to be reliable they are too expensive and complex to use in many studies For some large studies especially those with many centers or those in which lens changes are of secondary concern it would be useful to have a simple clinical lens grading system that is reliable and that can be used with minimal training of examiners Several clinical lens grading systems have been developed and found to be reliable in the hands of dedicated lens researchers but the systems have been difficult for other ophthalmologists to use reliably
The Age-Related Eye Disease Study AREDA has developed a simplified clinical cataract grading system to assess the severity of nuclear cortical and posterior subcapsular cataracts the 3 main types of age-related cataract The system is designed to require minimal examiner training for persons already proficient in the use of the slit lamp A total 150 participants with cataracts of varying severity who are already participating in other NEI protocols will be recruited to evaluate the reliability of the system After being dilated each participant will have a lens grading performed independently by 2 examiners To provide information on the validity of the clinical gradings lens photographs will be taken and graded using the detailed AREDS system for grading photographs The data will allow us to evaluate 1 the agreement between the AREDS clinical lens grading system and the AREDS photographic system of grading lens opacities and 2 the agreement on assessment of cataract severity among opthalmologists with varying subspecialty using the AREDS clinical lens grading method
The Age-Related Eye Disease Study AREDA has developed a simplified clinical cataract grading system to assess the severity of nuclear cortical and posterior subcapsular cataracts the 3 main types of age-related cataract The system is designed to require minimal examiner training for persons already proficient in the use of the slit lamp A total 150 participants with cataracts of varying severity who are already participating in other NEI protocols will be recruited to evaluate the reliability of the system After being dilated each participant will have a lens grading performed independently by 2 examiners To provide information on the validity of the clinical gradings lens photographs will be taken and graded using the detailed AREDS system for grading photographs The data will allow us to evaluate 1 the agreement between the AREDS clinical lens grading system and the AREDS photographic system of grading lens opacities and 2 the agreement on assessment of cataract severity among opthalmologists with varying subspecialty using the AREDS clinical lens grading method
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 |
|---|---|---|---|
| 04-EI-0128 | None | None | None |