Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator

NCT03166202 | Completed

• 1 other identifier: 228382017
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Previous work collectively suggests that rod-mediated dark adaptation (RMDA) is a promising candidate as a functional endpoint measure for evaluating interventions to slow early progression of age-related macular degeneration (AMD). However, there is no agreement among the clinical, research and regulatory communities as to what constitutes a clinically (practically) significant slowing in RMDA. Treatments for AMD are often not considered efficacious if they do not result in a criterion level of improvement in vision. But how much change in the rate of dark adaptation constitutes a clinically significant change? Until this issue is resolved, progress in developing clinical trials on early AMD are at a standstill since there is no functional endpoint to be used in the trial. One approach to establishing clinical significance is to examine how RMDA relates to the performance of an everyday visual task under low luminance conditions, such as night driving or reading. However, such data are not yet available. The purpose of this project is to examine the relationship between RMDA and night-time driving and reading under poor illumination. This information will guide the development of a definition of a clinically significant difference in RMDA that can be used in designing clinical trials on early AMD.

Conditions

Age-related Macular Degeneration

Keywords

age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• rod intercept time

  rate of rod-mediated dark adaptation

  measured once (1 day)

Secondary Outcomes (1)

• severity of age-related macular degeneration

  measured once (1 day)

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults living in the community who have current driver's license who have age-related macular degeneration

You may qualify if:

• age-related macular degeneration in one or both eyes, ability to follow simple instructions, licensed to drive a vehicle, can read and speak English

You may not qualify if:

• diabetes, retinal or optic nerve conditions other than age-related macular degeneration, neurological conditions that impair vision

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Callahan Eye Hospital, UAB Dept of Ophthalmolog & Visual Sciences

Birmingham, Alabama, 35294-0009, United States

Location

Related Publications (1)

• Owsley C, McGwin G Jr, Clark ME, Jackson GR, Callahan MA, Kline LB, Witherspoon CD, Curcio CA. Delayed Rod-Mediated Dark Adaptation Is a Functional Biomarker for Incident Early Age-Related Macular Degeneration. Ophthalmology. 2016 Feb;123(2):344-351. doi: 10.1016/j.ophtha.2015.09.041. Epub 2015 Oct 30.

  PMID: 26522707 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Cynthia Owsley, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• MiYoung Kwon, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 25, 2017
• Study Start: September 1, 2018
• Primary Completion: March 5, 2019
• Study Completion: March 5, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

US (1)