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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01822873
First Posted: April 2, 2013
Last Update Posted: November 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Duke University
  Purpose

The study hypothesis is that patients with dry age-related macular degeneration experience visual function impairments such as defects in dark adaptation, glare intolerance, poor light transition and reading in low lighting conditions. Studies have shown that patients in the early phases of AMD with normal visual acuity commonly reported difficulty with these visual functions but there have been no systematic studies evaluating these deficits in this population.

This prospective, exploratory study will include up to 130 patients with dry AMD and 60 controls. These patients will undergo the following non-invasive visual function testing:

  • microperimetry with eye tracking
  • low luminance visual acuity
  • specialized color vision (cone-specific)
  • contrast testing and night vision testing.

High-resolution spectral domain optical coherence tomography (SDOCT) images will be taken of the central retina using the Spectralis OCT unit. The values of visual function tested will be correlated with the findings on SDOCT (volume/amount of drusen present in early AMD).

There are no known risks to the subjects beyond what is normal for standard examinations of the eye, visual function testing and standard ocular photographic procedures.


Condition
Age Related Macular Degeneration

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Visual Function Impairments in Patients With Early Dry Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in low luminance visual acuity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ]

Secondary Outcome Measures:
  • Change in cone specific contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ]
  • Change in contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ]
  • Change in macular sensitivity on microperimetry [ Time Frame: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months ]

Estimated Enrollment: 210
Study Start Date: March 2013
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
Age-related macular degeneration

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be identified from patients of the Duke Eye Center presenting for ophthalmologic consultation. Patients with dry AMD are routinely available from this clinic and will be the primary study group.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822873


Locations
United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Hoffmann-La Roche
Investigators
Principal Investigator: Eleonora Lad, MD, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01822873     History of Changes
Other Study ID Numbers: Pro00036248
First Submitted: March 28, 2013
First Posted: April 2, 2013
Last Update Posted: November 23, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases