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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01822873
First received: March 28, 2013
Last updated: August 19, 2014
Last verified: August 2014
  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: Pilot Study Evaluating Visual Function Impairments in Patients With 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: 3, 6 and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in cone specific contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • Change in contrast sensitivity [ Time Frame: Arm 1: 1-2 months. Arm 2: 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • Change in macular sensitivity on microperimetry [ Time Frame: Arm 1: 1-2 months. Arm 2: 3, 6 and 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: March 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
Age-related macular degeneration

Detailed Description:

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 150 patients (100 dry AMD patients and 50 controls) with the goal of evaluating the changes in visual function in dry AMD as compared to age-matched control subjects. Study will include patients determined on examination have dry AMD as well as age-matched normal control subjects without dry AMD. If two eyes satisfy the inclusion criteria, both eyes will be tested.

The patients first will undergo microperimetry testing, which incorporates an eye tracker that operates independently of the microperimeter and is able to compare results with a reference database of normal subjects. A Line Scanning Laser Ophthalmoscope (SLO) is used to capture confocal images of the retina. Using the SLO image, the operator can see the area to test. For follow-up examinations, the same area will be tested and the machine generates a report on change from previous examination. The test takes approximately 5 minutes.

Patients will then undergo low luminance visual acuity using a computer-based test followed by cone specific vision testing. The cone contrast test (CCT) is a computer-based color test that rapidly identifies type (red, green, or blue) and severity (mild, moderate, and severe) of color deficiency, quantifies color performance, and allows early detection of acquired color deficiency. The automated test takes approximately 5 minutes to complete for all three cone tones; studies have shown impairment in blue and green cones in AMD. The system also provides tests for low contrast sensitivity, night vision (simulate low lighting conditions, with darker background).

Using computerized visual acuity charts, the patients will also be tested for contrast sensitivity. The duration of each test can vary but typically lasts for 10-15 minutes.

Follow-up visual function testing will be performed at different timepoints depending on the Arm of the study: at 1-2 months for Arm 1 and approximately 3, 6 and 9 months for Arm 2 using the same protocol, based on standard of care clinic visits.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 18 years of age

Exclusion Criteria:

  1. Unable or unwilling to give consent
  2. Under 18 years of age
  3. Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid, and other macular pathology other than AMD
  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: NCT01822873

Locations
United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Eleonora Lad, MD, PhD    919-684-9010      
Principal Investigator: Eleonora Lad, MD, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Eleonora Lad, MD, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01822873     History of Changes
Other Study ID Numbers: Pro00036248
Study First Received: March 28, 2013
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 15, 2014