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Compensation: Varies

Number of Visits: 8

34 Participants Needed

Biofeedback for Nystagmus

Overseen BySamuel Markowitz, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Monica Daibert Nido

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

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment Biofeedback Training for Nystagmus?

Research shows that biofeedback training can help people with nystagmus (a condition causing involuntary eye movements) by reducing the severity of eye movements and improving vision. Studies have found that patients can learn to control their eye movements better, leading to improved visual stability and quality of life.¹ ² ³ ⁴ ⁵

Is biofeedback training safe for treating nystagmus?

The studies on biofeedback training for nystagmus do not report any safety concerns, suggesting it is generally safe for use in humans.¹ ² ³ ⁵ ⁶

How does biofeedback training differ from other treatments for nystagmus?

Biofeedback training for nystagmus is unique because it helps patients gain voluntary control over their eye movements by providing real-time feedback, allowing them to reduce the intensity and frequency of their eye movements. This approach can improve visual functions and quality of life without the need for medication or surgery, making it a non-invasive alternative to traditional treatments.¹ ² ³ ⁴ ⁷

Research Team

Samuel Markowitz, MD

Principal Investigator

University of Toronto

Eligibility Criteria

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.

Inclusion Criteria

You have been diagnosed with infantile idiopathic nystagmus (IIN).

Ability to follow the visual and auditory stimuli and training instructions

Exclusion Criteria

Both of your eyes have cloudy areas that make it hard to do a certain type of eye test.

You cannot complete the required tests and training.

You have eye conditions that are not related to nystagmus.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including visual acuity, fixation stability, and quality of life estimates

1 day

1 visit (in-person)

Biofeedback Training

Participants undergo 4 biofeedback training sessions to improve oculomotor control and visual acuity

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in visual acuity and quality of life post-training

4 months

2 visits (in-person)

Treatment Details

Interventions

Biofeedback Training
Sham - simulated BT

Trial OverviewThe 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.

Participant Groups

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.