What is the mechanism of action of this treatment?

Biofeedback Training (BT) for Low Vision involves using real-time feedback from physiological functions to improve oculomotor control. This technique helps patients learn to control eye movements more effectively by providing visual or auditory signals that guide them in adjusting their eye position and movement. The primary mechanism of action is the enhancement of neuromuscular coordination and visual processing through repeated practice and feedback. This matters for Low Vision patients because improved oculomotor control can lead to better visual stability and accuracy, thereby enhancing their ability to perform daily tasks and improving overall quality of life.

What side effects are associated with this type of intervention?

Biofeedback Training (BT) for improving oculomotor control in low vision cases, such as those with Infantile Idiopathic Nystagmus, is a relatively new technique and specific side effects are not well-documented. Generally, treatments for low vision, including various forms of visual rehabilitation and assistive technologies, are considered low-risk. However, potential side effects may include eye strain, headaches, and temporary discomfort during the adaptation period. It is important for patients to consult with their healthcare provider to monitor any adverse effects and adjust the treatment plan as necessary.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for treatments directly analogous to biofeedback training (BT) for improving oculomotor control in low vision. However, treatments for low vision generally include a range of rehabilitative techniques and pharmacological interventions aimed at enhancing visual function and quality of life. These may involve the use of assistive devices, vision therapy, and medications to manage underlying conditions contributing to low vision.

What other types of research exist?

Promising, novel alternatives to Biofeedback Training (BT) for Low Vision patients include: 1) Cognitive Behavioral Therapy (CBT) for its adaptability in treating various conditions and potential application in managing psychological aspects of low vision. 2) Deep Brain Stimulation (DBS), although primarily used for neurological conditions, shows potential for adaptation in treating oculomotor control issues. 3) Acupuncture and electro-therapy, which have shown benefits in other eye-related conditions and could be explored for low vision rehabilitation.

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Behavioural Intervention

Biofeedback for Nystagmus

N/A

Recruiting

Led By Samuel Markowitz, MD

Research Sponsored by Monica Daibert Nido

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days from baseline (v2), 14 days (v3), 21 days (v4), 28 days (v5), 35 days (v6), and 118 days from baseline (v7)

Summary

This trial tests a new technique to help infants with uncontrolled eye movements improve their vision. The technique uses visual and audio cues to teach better eye control, aiming to make vision clearer and more stable. The study will see if this method can help these patients see better at different distances. This technique has been used in visual training to help patients become aware of their eye movements and improve certain eye conditions.

Who is the study for?

This trial is for individuals diagnosed with Infantile Idiopathic Nystagmus (IIN) who can follow visual and auditory instructions. It's not suitable for those with eye conditions that affect testing, inability to perform during tests, or other types of nystagmus besides IIN.

What is being tested?

The study is evaluating Biofeedback Training (BT), a new technique in low vision rehabilitation aimed at improving eye movement control. Participants will be compared to a control group receiving simulated BT to measure the effectiveness of the real intervention.

What are the potential side effects?

Since this trial involves training rather than medication, traditional side effects are not expected. However, participants may experience fatigue or frustration related to the exercises.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days from baseline (v2), 14 days (v3), 21 days (v4), 28 days (v5), 35 days (v6), and 118 days from baseline (v7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days from baseline (v2), 14 days (v3), 21 days (v4), 28 days (v5), 35 days (v6), and 118 days from baseline (v7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days from baseline (v2), 14 days (v3), 21 days (v4), 28 days (v5), 35 days (v6), and 118 days from baseline (v7) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Best Corrected Visual Acuity for Distance Vision across BT sessions and post BT

Changes in Fixation Stability (Bivariate contour ellipse area) across BT sessions and post BT

Secondary study objectives

Changes in Contrast Sensitivity for near vision across BT sessions and post BT

Changes in Quality of Life Parental Questionnaire across BT and post BT

Changes in Reading speed across BT sessions and post BT

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Group A (treatment)Active Control1 Intervention

Each session includes 20 minutes of training each with rest as needed. The procedure involves presentation of a standard LED fixation target (FT) consisting of a small red circle of about 0.76° diameter. A fixation training target (FTT) will be selected by the trainer at a perceived better fixation point. Initially the participant will be instructed to stare at the FT circle. Following this stage the participant will be guided to look in the direction of the FTT and listen simultaneously to the audio feedback. As performing this task, the participant will actively control the eye movements until the audio feedback becomes more frequent and then becomes a continuous sound pattern. This continuous sound will signalize to the patient that the FTT location was reached. Participants will be given take-home efficiency reading exercises.

Group II: Group B (control)Placebo Group1 Intervention

The simulated biofeedback training for Group B involves the following procedure: For four weeks, presentation of a C10-2 microperimetry program. The procedure involves presentation of a standard LED fixation target (FT) consisting of a small red circle of about 0.76° diameter. Initially the participant will be instructed to stare at the FT circle. Following this stage the participant will be guided to look at the FT and simultaneously to be aware of any flashing lights in the periphery of vision. As performing this task, the participant will actively control the eye movements and similar to computer games, the patient has to identify targets in the peripheral field of vision and respond by pressing a button. Participants will be given take-home efficiency reading exercises.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Biofeedback Training (BT) for Low Vision involves using real-time feedback from physiological functions to improve oculomotor control. This technique helps patients learn to control eye movements more effectively by providing visual or auditory signals that guide them in adjusting their eye position and movement. The primary mechanism of action is the enhancement of neuromuscular coordination and visual processing through repeated practice and feedback. This matters for Low Vision patients because improved oculomotor control can lead to better visual stability and accuracy, thereby enhancing their ability to perform daily tasks and improving overall quality of life.