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Home > "E" Clinical Trials Conditions > Evaluation of the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System  Evaluation of the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System
Evaluation of the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System
For Condition:
Status: Recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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.
Details: 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. After a thirty minute interval, the examinations will be repeated on the same day. To provide information on the validity of the clinical gradings, lens photographs will be taken and graded using the same simple classification system as well as the detailed AREDS system for grading photographs. The data will allow us to address the following questions: -What are the inter- and intra-observer variances of the simplified AREDS clinical lens grading system? -Is the AREDS clinical lens grading system reproducible among ophthalmologists with varying subspecialty training? -What is the correlation between the AREDS clinical lens grading system and the AREDS photographic system of grading lens opacities?
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 1. Patient must understand and sign the informed consent. 2. Patient must be at least 18 years of age. 3. Pupillary dilation to at least 6 mm must be possible. 4. About 50 participants (+/-5) to be recruited with each of the 3 cataract types, with at least 8 participants in each severity grade. EXCLUSION CRITERIA: Patients below the age of 18 will be excluded from participationin this study of age-related cataract. 1. Any condition such as corneal opacification that precludes adequate slit lamp examination and photography of the lens.
Total Enrollment: 150
Location and Contact Information:
National Eye Institute (NEI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040128; 04-EI-0128
Study Start Date: February 19, 2004
Record last reviewed: April 19, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078299
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Evaluation of the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System
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