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

June 5, 2019 updated by: Cynthia Owsley, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Detailed Description

The specific aims of this study are as follows:

Aim 1: To examine the association between RMDA as assessed by the rod intercept time and self reported driving difficulty and experiences during night time driving.

Aim 2: To examine the association between RMDA as assessed by rod intercept time and reading performance as assessed by the MNREAD test administered under a low light level. Reading performance will be defined in terms of maximum reading speed, critical print size (i.e., the smallest print size that supports maximum reading speed), reading acuity (i.e., the smallest print size that can be just read) and the reading accessibility index (i.e., an individual's access to text over the range of print sizes found in everyday life).

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0009
        • Callahan Eye Hospital, UAB Dept of Ophthalmolog & Visual Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rod intercept time
Time Frame: measured once (1 day)
rate of rod-mediated dark adaptation
measured once (1 day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity of age-related macular degeneration
Time Frame: measured once (1 day)
defined by grading of color fundus photos
measured once (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: MiYoung Kwon, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

March 5, 2019

Study Completion (Actual)

March 5, 2019

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 228382017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Once study is completed and published in the peer review literature, we will arrange for a data sharing process with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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