← Back to Search

Combination Training + Visual Sensitivity Training for Macular Degeneration(FLAP Trial)

N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-89
Severely impaired vision in both eyes (20/100 or worse)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline and within 3 weeks of training completion, training is complete 7 weeks from baseline on average
Awards & highlights
No Placebo-Only Group

FLAP Trial Summary

This trial seeks to better understand how the brain adapts to vision loss in order to develop new therapies to improve quality of life for those with low vision.

Eligible Conditions
  • Age-Related Macular Degeneration
  • Central Vision Loss

FLAP Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You are between 18 and 89 years old.
Select...
You have very poor vision in both eyes (20/100 or worse).
Select...
You have been diagnosed with macular degeneration by an eye doctor.
Select...
You have more severe light sensitivity in the center of your retina compared to the edges.
Select...
Your medical records show that you have had this level of illness for at least 2 years.

FLAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and within 3 weeks of training completion, training is complete 7 weeks from baseline on average
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and within 3 weeks of training completion, training is complete 7 weeks from baseline on average for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline Fixation Stability after Completion of Training at approximately 7 weeks
Change from Baseline Radial Bias from the Crowding Task after completion of Training at approximately 7 weeks
Change from Baseline Saccadic Precision after Completion of Training at approximately 7 weeks
Other outcome measures
Change from Baseline Acuity after Completion of Training at approximately 7 weeks
Change from Baseline Completion time in the trail making task after Completion of Training at approximately 7 weeks
Change from Baseline Contrast Sensitivity after Completion of Training at approximately 7 weeks
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

FLAP Trial Design

2Treatment groups
Experimental Treatment
Group I: Training visual sensitivityExperimental Treatment1 Intervention
A standard Perceptual Learning approach to train early visual processes of discriminating the orientation of Gabor patches presented at threshold- level contrast. Preliminary data, using this method, in normally seeing and MD participants show both feasibility and preliminary evidence that this training gives rise to improvements in acuity.
Group II: Combination trainingExperimental Treatment1 Intervention
In combination training, investigators test the extent to which a combined training gives rise to the joint benefits of each training individually, or integrative benefits potentially surpassing benefits of the individual training alone. The visual sensitivity task will alternate across blocks with the spatial integration task, using the timing of targets and location switches from spatial attention training.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,524 Previous Clinical Trials
2,259,438 Total Patients Enrolled
University of California, RiversideOTHER
23 Previous Clinical Trials
14,880 Total Patients Enrolled

Media Library

Combination training Clinical Trial Eligibility Overview. Trial Name: NCT05454124 — N/A
Age-Related Macular Degeneration Research Study Groups: Combination training, Training visual sensitivity
Age-Related Macular Degeneration Clinical Trial 2023: Combination training Highlights & Side Effects. Trial Name: NCT05454124 — N/A
Combination training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05454124 — N/A

Frequently Asked Questions

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

Is there an opportunity for me to partake in this research?

"This clinical trial seeks to enroll 60 individuals with macular degeneration aged between 18 and 89 years old. In order to be eligible, they must also have severely impaired vision in both eyes (20/100 or worse), a prior diagnosis of Macular Degeneration by an Ophthalmologist, light sensitivity in the macula that is at least 10 dB units more than peripheral regions as confirmed using MAIA technology scans, and documented evidence indicating a minimum two year period of this level of eye disease severity."

Answered by AI

Is the recruitment process for this experiment still open?

"Affirmed, the clinical trial is currently recruiting participants. The data posted on clinicaltrials.gov indicates that this experiment was initiated November 1st 2022 and its records were most recently amended October 31st 2022."

Answered by AI

How many participants has this research initiative recruited?

"Affirmative, the clinicaltrials.gov website states that this trial is currently seeking participants. It was first posted on November 1st 2022 and has seen its last update on October 31st 2022. 60 patients are planned to be enrolled from a single medical site."

Answered by AI

Does this trial accept participants aged twenty or more?

"This trial is seeking adult participants aged 18 and under 89."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Factors in Learning And Plasticity: Macular Degeneration
Kristina M Visscher 2022. "Factors in Learning And Plasticity: Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05454124.
All > Age Related Macular Degeneration > Stargardt Disease
~26 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top