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

NCT01822873 | Completed

• 1 other identifier: Pro00036248
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Change in low luminance visual acuity

  Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months

Secondary Outcomes (3)

• Change in cone specific contrast sensitivity

  Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months

• Change in contrast sensitivity

  Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months

• Change in macular sensitivity on microperimetry

  Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months

Study Arms (2)

Normal

Age-related macular degeneration

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Capable and willing to provide consent
• Has been diagnosed with dry age-related macular degeneration stages 1-3
• At least 50 years of age

You may not qualify if:

• Unable or unwilling to give consent
• Under 50 years of age
• Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid, and other macular pathology other than AMD
• Presence of dense cataracts in the study eye(s) that can affect visual function tests
• Presence of glaucoma requiring treatment during the study and/or visual field defects
• Presence retinal laser or surgical theraphy in study eye (s)
• Any of other ocular condition requiring long-term theraphy or surgery during the study
• Participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing
• Diagnosis of nystagmus that will interfere with testing
• High myopia -8 Diopters or more severe
• 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.

Sponsors & Collaborators

• Duke University: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• Cocce KJ, Stinnett SS, Luhmann UFO, Vajzovic L, Horne A, Schuman SG, Toth CA, Cousins SW, Lad EM. Visual Function Metrics in Early and Intermediate Dry Age-related Macular Degeneration for Use as Clinical Trial Endpoints. Am J Ophthalmol. 2018 May;189:127-138. doi: 10.1016/j.ajo.2018.02.012. Epub 2018 Mar 15.

  PMID: 29477964 RESULT

• Thompson AC, Luhmann UFO, Stinnett SS, Vajzovic L, Horne A, Toth CA, Cousins SW, Lad EM. Association of Low Luminance Questionnaire With Objective Functional Measures in Early and Intermediate Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2018 Jan 1;59(1):289-297. doi: 10.1167/iovs.17-22528.

  PMID: 29340643 RESULT

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Eleonora Lad, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 2, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-02

Locations

US (1)