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Visual Performance Assessment for Eye Diseases

N/A
Waitlist Available
Led By Henry Tseng, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will help better understand the impact of visual impairment on daily task performance in patients with eye diseases of the visual pathways, such as glaucoma and age-related macular degeneration (AMD).

Who is the study for?
This trial is for people aged 18-90 with visual impairments due to conditions like glaucoma or macular degeneration, and healthy individuals as controls. Participants must be able to consent and follow instructions. Those with systemic conditions that could interfere with test completion are excluded.Check my eligibility
What is being tested?
The study aims to understand how eye diseases affect daily tasks by testing patients biannually using ophthalmological exams, psychophysical tests, eye tracking, EEGs, driving simulators, VR, balance assessments, and questionnaires. It also evaluates if brain-computer interface technology can track disease progression.See study design
What are the potential side effects?
Since the interventions involve non-invasive tests rather than medications or surgeries, side effects may include discomfort from prolonged eye examinations or fatigue from participating in multiple assessments during visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of eyes showing progression
Time to detect progression measured in years
Visual impairment measured by visual functioning test
Secondary outcome measures
Patient-reported quality of life as measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25
Standard automated perimetry will be assessed by the c-index

Trial Design

7Treatment groups
Experimental Treatment
Group I: Suspicious of having glaucoma groupExperimental Treatment2 Interventions
Patients with suspicious of having glaucoma will be in the group for up to 5 years.
Group II: Retinal degenerations groupExperimental Treatment1 Intervention
Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years.
Group III: Other diseases of visual pathways groupExperimental Treatment1 Intervention
Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years.
Group IV: Non-glaucomatous optic neuropathies groupExperimental Treatment1 Intervention
Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years.
Group V: Healthy control groupExperimental Treatment2 Interventions
Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years.
Group VI: Glaucoma groupExperimental Treatment2 Interventions
Patients with diagnosed glaucoma will be in the group for up to 5 years.
Group VII: Age-related macular degeneration (AMD) groupExperimental Treatment1 Intervention
Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brain-computer interface
2018
N/A
~420
Visual Performance tests
2018
N/A
~120

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,813 Total Patients Enrolled
University of MiamiLead Sponsor
898 Previous Clinical Trials
409,536 Total Patients Enrolled
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,954 Total Patients Enrolled

Media Library

Visual Performance tests Clinical Trial Eligibility Overview. Trial Name: NCT03318549 — N/A
Optic Neuropathy Research Study Groups: Retinal degenerations group, Non-glaucomatous optic neuropathies group, Age-related macular degeneration (AMD) group, Suspicious of having glaucoma group, Glaucoma group, Other diseases of visual pathways group, Healthy control group
Optic Neuropathy Clinical Trial 2023: Visual Performance tests Highlights & Side Effects. Trial Name: NCT03318549 — N/A
Visual Performance tests 2023 Treatment Timeline for Medical Study. Trial Name: NCT03318549 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become involved in this research initiative?

"This research trial seeks to recruit approximately 250 patients with retinal degeneration between the ages of majority and nonagenarian."

Answered by AI

Are there any opportunities to join this experiment right now?

"Clinicaltrials.gov indicates that this experiment is not presently recruiting patients, despite first being posted on October 29th 2018 and most recently edited on April 11th 2022. Although 378 other studies are actively seeking participants as of now."

Answered by AI

Is the upper age limit for participation in this trial restricted to 30 years old or higher?

"According to the enrollment prerequisites, this trial requires participants to be between 18 and 90 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
Felipe Andrade Medeiros 2018. "BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03318549.
~18 spots leftby Apr 2025
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