Vision Training for Low Vision

(FLAP Trial)

Recruiting at 1 trial location

Overseen By Rachel A Chua, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pacemaker, Claustrophobia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover new ways to help people with low vision improve their sight. It tests various training methods, such as focusing on detail, combining visual information, and shifting attention. Each method trains the brain to see better, even if the eyes struggle. Individuals with corrected vision of 20/40 or better who have not experienced retinal issues might be suitable for this study. As an unphased trial, it provides a unique opportunity to explore innovative methods for enhancing vision without the constraints of traditional clinical trial phases.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these training methods are safe for individuals with low vision?

Research shows that vision training techniques for people with low vision are generally safe. Although specific safety details for these methods aren't always available, past studies on similar programs have shown positive outcomes. For instance, orientation and mobility training, a type of vision rehabilitation, has improved quality of life and helped people with vision loss become more independent, indicating that the training is well-tolerated.

Additionally, research on spatial cognitive training for low vision rehabilitation highlights the benefits of these programs without reporting significant side effects. These methods are non-invasive and focus on improving visual skills through exercises and tasks, making them safe for participants.

It's important to understand that the current trial is in an early research phase, meaning the treatment is still being evaluated and safety data might be limited. However, similar treatments have been used effectively and safely in other vision training settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these vision training methods for low vision because they target different aspects of visual processing that are not the primary focus of current treatments. Unlike standard options that might rely on optical aids or medications, these methods aim to enhance the brain's ability to process visual information. Training visual sensitivity improves the ability to detect faint visual cues, while spatial integration training helps with recognizing objects by blending visual elements. Spatial attention training is designed to enhance the ability to focus and shift attention in the visual field, similar to how we naturally view our surroundings. The combination training brings all these elements together, potentially offering enhanced visual function beyond what any single approach can provide.

What evidence suggests that this trial's treatments could be effective for low vision?

Research has shown that certain training can help people with low vision by improving how the brain processes visual information. This trial will evaluate different training methods, each in separate treatment arms. One arm focuses on training spatial integration, aiding in the recognition of objects and faces by integrating visual features. Another arm involves training spatial attention, enhancing the ability to focus and shift attention between different things, maximizing the use of remaining vision. A third arm trains visual sensitivity, improving the ability to notice details more clearly. Additionally, a combination training arm will test whether using these methods together provides even greater benefits, as each one helps different parts of vision work better together. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have good vision (20/40 or better).

I have no history of eye diseases affecting the retina.

Exclusion Criteria

You weigh more than 300 pounds.

Metal of any type implanted in their head (limited dental work is acceptable)

You have very old or bright tattoos, especially near your head.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo training in visual sensitivity, spatial integration, and spatial attention over a 7-week period.

7 weeks

Follow-up

Participants are monitored for changes in visual and neural metrics after training completion.

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combination training
• Training spatial attention
• Training spatial integration
• Training visual sensitivity

Trial Overview 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.

How Is the Trial Designed?

Group I: Condition 4: Combination training Experimental Treatment 1 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 attention Experimental Treatment 1 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 integration Experimental Treatment 1 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 sensitivity Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of California, Riverside

Collaborator

Trials

33

Recruited

14,400+

Published Research Related to This Trial

Training low vision patients to effectively use low vision aids is crucial for improving their quality of life and independence.

A team approach, involving various experts, enhances the training process, making it a vital component of follow-up care in low vision rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training low vision patients. Kelleher, DK.[2004]

The vision trainer rehabilitation technique significantly improved retinal function and visual acuity in young patients with amblyopia, as evidenced by increased pattern electroretinogram (PERG) amplitudes and better best corrected visual acuity (BCVA) after 10 weeks of treatment.

This study suggests that the vision trainer program could serve as a beneficial addition to traditional amblyopia treatments, even in patients outside the critical visual development period, highlighting its potential for enhancing visual outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of vision trainer rehabilitation in patients affected by anisometropic amblyopia: electrofunctional evaluation. Esposito Veneruso, P., Ziccardi, L., Magli, G., et al.[2022]

The Acquired Monocular Vision Rehabilitation (AMVR) program effectively enhances the skills and independence of monocular patients, as demonstrated in a case report involving a patient who showed increased self-confidence and improved motor skills after a year of rehabilitation.

The program highlights the importance of tailored rehabilitation for monocular patients, suggesting that such interventions can prevent depression and improve overall quality of life, warranting further research and integration into existing vision rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision rehabilitation team management of acquired monocular vision. Ihrig, C.[2013]

Only 11.4% of patients with irreversible bilateral vision impairment and 1.9% with unilateral impairment were referred to low-vision rehabilitation services by ophthalmologists, indicating a significant gap in access to care.

Despite most patients expressing concern about their vision impairment and reporting difficulties in daily activities, there is a clear need for improved education among ophthalmologists regarding the importance of referring patients to low-vision rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation Referral for Patients With Irreversible Vision Impairment Seen in a Public Safety-Net Eye Clinic. Coker, MA., Huisingh, CE., McGwin, G., et al.[2019]

Low vision is defined as having a visual acuity of 20/70 or worse in the better-seeing eye, which cannot be corrected with regular eyeglasses, significantly affecting daily activities like reading and walking.

Rehabilitation for low vision is a personalized, multidisciplinary approach aimed at enhancing functional abilities and improving the quality of life for individuals, tailored to their specific needs and underlying conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting Vision Rehabilitation. Meyniel, C., Bodaghi, B., Robert, PY.[2020]

Visual rehabilitation significantly improves the quality of life for individuals with low vision or blindness from untreatable causes by helping them use their remaining vision effectively.

A multidisciplinary approach is essential for successful low vision rehabilitation, which includes assessing visual functions, prescribing aids, and training patients to use these devices, while also incorporating new technological advancements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Modalities for Low Vision Rehabilitation. Agarwal, R., Tripathi, A.[2021]

A pilot program was conducted with occupational therapists lacking experience in low vision rehabilitation, resulting in the development of a best-practice model for training in this specialty area.

After three training sessions, the participating therapists achieved entry-level competency in low vision rehabilitation, suggesting that the model could effectively prepare students during their fieldwork placements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialty level II fieldwork in low vision rehabilitation. Nastasi, JA.[2013]

A survey of VA blind rehabilitation centers revealed that while 82% of optometrists prescribe eccentric viewing (EV) training, there is no consensus on the criteria for selecting the best area for training, indicating a lack of standardized practice.

The duration of EV training varies widely among patients, ranging from 20 minutes to nearly 24 hours, highlighting inconsistencies in training methods and the need for further research to evaluate the efficacy and cost-effectiveness of EV training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a standard of care for eccentric viewing training? Stelmack, JA., Massof, RW., Stelmack, TR.[2019]

Plasticity in the visual system refers to the brain's ability to adapt to visual impairment, which can significantly influence how individuals with low vision perform daily activities.

Recent advancements in imaging techniques and eye tracking are enhancing our understanding of visual plasticity, helping to develop effective rehabilitation strategies for those with low vision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Vision and Plasticity: Implications for Rehabilitation. Legge, GE., Chung, STL.[2021]

Citations

1. nature.com nature.com/articles/s41598-025-21763-3

Predicting motor rehabilitation outcomes in children with ... The nomogram effectively predicts rehabilitation outcomes in children with low vision receiving somatosensory-based training. This tool can ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10970319/

The Effect of Vocational Training on Visually Impaired ... Conclusion: Vocational training significantly improves the overall QOL for visually impaired individuals. It is noteworthy that the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6746574/

Clinically Meaningful Rehabilitation Outcomes of Low ... We learned that outpatient LVR services across the United States were effective in improving overall visual ability in nearly half (47%) of patients, with large ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0039625711001354

How Effective is Low Vision Service Provision? A ... There are some good data on the performance of particular types of intervention, but almost no useful data about outcomes in children, those of working age, and ...

5. researchgate.net researchgate.net/publication/355204177_Efficacy_of_Visual_Training_Program_for_Students_with_Visual_Impairment

Efficacy of Visual Training Program for Students with ... Results showed statistically significant improvement in the visual perceptual and visual-motor integration skills. There was not any statistically significant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7138242/

Orientation and mobility training for adults with low vision - PMC Orientation and mobility (O&M) training is provided to people who are visually impaired to help them maintain travel independence.

7. journalofsportsmedicine.org journalofsportsmedicine.org/full-text/621/eng

Exercise programming for individuals with vision loss The aim of this review is to emphasize the importance of aerobic and strength exercises for underserved IWVL population by summarizing the information.

8. withpower.com withpower.com/trial/phase-vision-low-7-2022-519af

Vision Training for Low Vision (FLAP Trial) Is vision training for low vision generally safe for humans? The research does not provide specific safety data for vision training techniques, but these ...

9. bmjopen.bmj.com bmjopen.bmj.com/content/6/8/e011996

Visually Impaired OLder people's Exercise programme for ... This feasibility study aims to adapt the group-based Falls Management Exercise (FaME) programme to the needs of VIOP and carry out an external pilot trial.