Evaluation of the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00078299
First received: February 20, 2004
Last updated: March 3, 2008
Last verified: April 2005
  Purpose

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.


Condition
Cataract

Study Type: Observational
Official Title: Evaluation of the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 150
Study Start Date: February 2004
Estimated Study Completion Date: April 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. Patients must have at least one natural lens present.

EXCLUSION CRITERIA:

Patients below the age of 18 will be excluded from participation in this study of age-related cataract.

1. Any condition such as corneal opacification that precludes adequate slit lamp examination and photography of the lens.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078299

Locations
United States, Maryland
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00078299     History of Changes
Other Study ID Numbers: 040128, 04-EI-0128
Study First Received: February 20, 2004
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cortical
Nuclear Sclerosis
Posterior Subcapsular
Photographic Methods
Reproducibility (intra and interobserver)
Cataract
Agreement
Grading System

Additional relevant MeSH terms:
Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on July 29, 2014