Completed

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

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What is being collected

Data Collection

Who is being recruted

Cataract

+ Eye Diseases

+ Lens Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: February 2004
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleEvaluation of the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System 
NCT00078299
Principal SponsorNational Eye Institute (NEI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CataractEye DiseasesLens Diseases

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Eye Institute (NEI)

Bethesda, United StatesSee the location
CompletedOne Study Center