Study on Visual Function Impairments in Dry Age-related Macular Degeneration

Launched by DUKE UNIVERSITY · Mar 28, 2013

Keywords

ClinConnect Summary

This prospective, exploratory study will be performed in multiple arms:

A. Arm 1: a pilot study of up to 40 patients (30 patients with dry age-related macular degeneration and 10 normal age-matched controls) in order to test 1) the feasibility of performing the visual function tests in this population and 2) test/retest reliability over 1-2 months. If the pilot study reveals that the visual function tests proposed are feasible and have high reliability, the larger study (Phase 2) will be subsequently performed.

B. Arm 2: a study of up to 160 patients (130 dry AMD patients and 32 controls)...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Capable and willing to provide consent
• • 2. Has been diagnosed with dry age-related macular degeneration stages 1-3
• • 3. At least 50 years of age
• Exclusion Criteria:
• • 1. Unable or unwilling to give consent
• • 2. Under 50 years of age
• • 3. Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid, and other macular pathology other than AMD
• • 4. Presence of dense cataracts in the study eye(s) that can affect visual function tests
• • 5. Presence of glaucoma requiring treatment during the study and/or visual field defects
• • 6. Presence retinal laser or surgical theraphy in study eye (s)
• • 7. Any of other ocular condition requiring long-term theraphy or surgery during the study
• • 8. Participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing
• • 9. Diagnosis of nystagmus that will interfere with testing
• • 10. High myopia -8 Diopters or more severe
• • 11. Participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the stduy or may interfere with the study procedures, evaluations and outcome assessments.