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Vision Training for Low Vision (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 18-30

No reported incidence of retinal pathology.

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

Awards & highlights

FLAP Trial Summary

This trial looks at how different types of training and therapy can help people with low vision. The findings could help millions of people who suffer from this condition.

Who is the study for?

This trial is for individuals aged 18-30 with corrected vision of 20/40 or better and no retinal pathology. It's not suitable for those needing special glasses, over certain body size limits, pregnant, with pacemakers/metal implants (except some dental work), weighing over 300 pounds, claustrophobic, hearing-impaired, with extensive tattoos near the head, a history of serious head injury or hallucinations/delusions.Check my eligibility

What is being tested?

The study tests four training conditions to improve visual function in people with low vision: training visual sensitivity; spatial attention; spatial integration; and a combination of these methods. The goal is to understand how the brain adapts after central vision loss and develop new treatments.See study design

What are the potential side effects?

Since this trial involves non-invasive training exercises rather than medication or surgery, traditional side effects are not expected. However, participants may experience eye strain or fatigue from the visual tasks.

FLAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 30 years old.

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I have no history of eye diseases affecting the retina.

FLAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and within 3 weeks of training completion, training is complete 7 weeks from baseline on average

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

FLAP Trial Design

4Treatment groups

Experimental Treatment

Group I: Condition 4: Combination trainingExperimental Treatment1 Intervention

In Condition 4, investigators combine the elements of Conditions 1-3. The investigators test the extent to which a combined training gives rise to the joint benefits of each training individually, or integrative benefits potentially surpass the benefits of the individual training alone. The visual sensitivity task from Condition 1 will alternate across blocks with the spatial integration task from Condition 2, using the timing of targets and location switches from Condition 3; Gabors or contours are used as targets instead of the red- circle in Condition 3 and a fixation point is presented instead of distractors to maintain a similar stimulus configuration as Conditions 1 and 2.

Group II: Condition 3: Training spatial attentionExperimental Treatment1 Intervention

A key attribute of most real-world visual tasks is that individuals alternate shifting and holding attention and eye movements to different objects in the visual field while searching for and discriminating possible sources of visual information. To train this, investigators will implement a task structure that requires participants to alternate between holding and switching attention and making targeted eye movements. The basic task is to press a key whenever a red circle appears in a series of other colored circles, with a target presented every 2 to 4s. Participants must maintain vigilance for relatively long periods, detect objects in the near periphery, switch attention based upon exogenous and endogenous cues, and make eye- movements to move areas of spared vision to those locations. These are aspects of attention and eye movements not incorporated in Conditions 1 and 2.

Group III: Condition 2: Training spatial integrationExperimental Treatment1 Intervention

Most visual tasks involve integrating features to discriminate objects, therefore requiring brain areas that can integrate features from multiple receptive fields from early visual areas. Thus spatial integration involves what investigators refer to as mid-level vision. Spatial integration is a particular concern in developing a PRL since an area of the visual periphery that is best suited to discriminate a simple visual feature may not be appropriate to integrate information across objects, such as in reading or recognizing facial identity or expression. Investigators address this issue with a targeted spatial integration training approach developed by MPI Seitz and based on contour integration tasks used in previous PL studies to train mid-level visual processes. Target stimuli consist of contours formed by spaced Gabors. Difficulty of detecting the target is manipulated by varying orientation jitter of Gabors making up the target.

Group IV: Condition 1: 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,362 Total Patients Enrolled

University of California, RiversideOTHER

24 Previous Clinical Trials

12,136 Total Patients Enrolled

Media Library

Combination training Clinical Trial Eligibility Overview. Trial Name: NCT05439759 — N/A

Central Vision Loss Research Study Groups: Condition 2: Training spatial integration, Condition 3: Training spatial attention, Condition 1: Training visual sensitivity, Condition 4: Combination training

Central Vision Loss Clinical Trial 2023: Combination training Highlights & Side Effects. Trial Name: NCT05439759 — N/A

Combination training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05439759 — N/A

Frequently Asked Questions

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

Is the age restriction for this research limited to those below 70 years old?

"The parameters for entry into this clinical trial require that participants are between 18 and 30 years of age."

Answered by AI

Are recruitment efforts ongoing for this clinical experiment?

"Yes, the clinical trial is still ongoing. According to information shared on clinicaltrials.gov this trial was initiated on October 24th 2022 and underwent its latest revision of data on October 31st 2022."

Answered by AI

Are there specific criteria for qualifying to join this clinical experiment?

"To join this clinical trial, potential participants must have macular degeneration and be under 30 years of age. Currently, the research team is looking to enrol a cohort of 120 individuals."

Answered by AI

What is the overall number of participants in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical experiment is open for recruitment and was initially posted on October 24th 2022 with the latest edit being made on October 31st 2022. The trial necessitates 120 participants from a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Factors in Learning And Plasticity: Healthy Vision

Kristina M Visscher 2022. "Factors in Learning And Plasticity: Healthy Vision". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05439759.

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