Visual Function Tests in Age-related Macular Degeneration

NCT03275753 | Terminated

• 1 other identifier: 17-270-0001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess a battery of visual function tests in subjects with non-exudative age-related macular degeneration

Conditions

Age Related Macular Degeneration

Keywords

Visual function; Critical flicker fusion; Dark adaptation; Reading test

Outcome Measures

Primary Outcomes (1)

• Critical flicker fusion

  Critical flicker fusion will be tested using a computer based test for different stimulus colors, white, red, green and blue. A wide range of luminance and contrast levels will be tested. The subject would be seated in front of the monitor. The non-study eye will be occluded. Subjects would be given adequate practice tests prior to performing the actual test. The stimulus will be presented on the monitor screen and the subject indicates perceiving the stimulus by pressing a test button.

  At study visit through study completion, an average of 2 years

Secondary Outcomes (4)

• Dark adaptation

  At study visit through study completion, an average of 2 years

• Reading Tests

  At study visit through study completion, an average of 2 years

• Color vision function

  At study visit through study completion, an average of 2 years

• Shape discrimination

  At study visit through study completion, an average of 2 years

Study Arms (4)

Normal Population

VA of 20/25 or better in the study eye with no prior diagnosis of any retinal or ocular diseases

Other: Visual Function Tests

Early Dry AMD Population

VA of 20/40 or better in the study eye with clinical diagnosis of early dry AMD

Other: Visual Function Tests

Intermediate Dry AMD Population

VA of 20/40 or better in the study eye with clinical diagnosis of intermediate dry AMD

Other: Visual Function Tests

Advanced Dry AMD Population

Clinical diagnosis of advanced dry AMD in the study eye

Other: Visual Function Tests

Interventions

Visual Function Tests OTHER

All subjects will undergo a battery of visual function tests

Advanced Dry AMD Population; Early Dry AMD Population; Intermediate Dry AMD Population; Normal Population

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1: Normal Population (N=50) VA of 20/25 or better in the study eye with no prior diagnosis of any retinal or ocular diseases. Group 2: Early Dry AMD Population (N=50) VA of 20/40 or better in the study eye with clinical diagnosis of early dry AMD based on fundus features. Group 3: Intermediate Dry AMD Population (N=50) VA of 20/40 or better in the study eye with clinical diagnosis of intermediate dry AMD based on fundus features. Group 4: Advanced Dry AMD Population (N=50) Clinical diagnosis of advanced dry AMD based on fundus features in the study eye

You may qualify if:

• All Subjects Must:
• Be 60 years of age or older;
• Provide written informed consent;
• Be willing and able to follow all instructions and attend the study visits;
• Must be able to perform all study procedures;
• Normal Subjects:
• Have BCVA of 20/25 or better in the study eye;
• Have no history or clinical evidence of AMD, retinal diseases or any other ocular pathologies in either eye;
• AMD Subjects:
• Have BCVA of 20/40 or better in the study eye;
• Have a clinical diagnosis of non-exudative AMD in the study eye;

You may not qualify if:

• All subjects must not have any of the below criteria
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• Have a diagnosis of wet AMD in the study eye;
• Have any other hereditary or acquired retinal diseases in either eye ;
• Have glaucoma or other optic nerve diseases in either eye;
• Have corneal or other anterior segment diseases in either eye;
• Have significant cataract in the study eye;
• Have a history of ocular trauma or ocular surgery (other than cataract removal) in the study eye;
• Have a history of uncontrolled systemic disease (e.g. poorly controlled hypertension or poorly controlled diabetes);
• Have a history of seizures;
• On psychotropic medications;
• Any other symptoms or conditions that could, in the opinion of the investigator, interfere with study procedures.

Sponsors & Collaborators

• ORA, Inc.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jason Chin, OD

  ORA, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: September 8, 2017
• Study Start: September 21, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)