Actively Recruiting

Phase Not Applicable
Age: 5Years - 17Years
All Genders
ID04142307

Biofeedback Training to Improve Vision in Children with Idiopathic Infantile Nystagmus Syndrome

Led by Monica Daibert Nido · Updated on 2025-05-01

34

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying Infantile Idiopathic Nystagmus (IIN), a common eye movement disorder in children that causes involuntary eye motions and can affect visual acuity and quality of life. This study aims to evaluate the effects of biofeedback training (BT), a new technique using microperimetry devices, on controlling eye movements and improving vision in children with IIN. The goal is to develop guidelines for using BT in nystagmus cases based on systematic assessment. Participants will be randomly assigned to one of two groups: one receiving active biofeedback training and the other receiving simulated (sham) training. The active BT sessions involve visual and audio feedback to help patients control their eye movements using a fixation target and training target, with four sessions lasting about 20 minutes each over four weeks. The simulated training includes a computer game-like task involving peripheral vision targets and is also conducted over four weekly sessions. Both groups receive take-home reading exercises to support the training. Throughout the study, children will undergo baseline assessments including distance and near vision tests, fixation stability, nystagmus amplitude, contrast sensitivity, stereopsis, and quality of life questionnaires. Follow-up visits occur one week and three months after training completion to measure changes in visual acuity, fixation stability, reading speed, and other vision-related outcomes. The study lasts up to 24 months, with careful monitoring for any discomfort or fatigue during training, although no significant risks are expected.

CONDITIONS

Brief Title

Biofeedback in Idiopathic Infantile Nystagmus Syndrome

Who Can Participate

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Infantile Idiopathic Nystagmus (IIN)
  • Able to follow visual and auditory training instructions
  • Age between 5 and 17 years
Not Eligible

You will not qualify if you...

  • Presence of other eye diseases unrelated to nystagmus
  • Media opacity in both eyes impairing microperimetry testing
  • Peripheral nystagmus cases
  • Other types of nystagmus besides IIN
  • Inability to perform during testing and training

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and baseline assessments

Treatment

Duration - 4 weeks

Participants undergo 4 weekly biofeedback training sessions or simulated training sessions to improve eye movement control and fixation stability, with take-home reading exercises provided.

4 weekly visits (in-person) for training sessions

Follow-up

Duration - Up to 4 months after baseline

Participants return for follow-up visits to assess vision, fixation stability, and quality of life after the training sessions.

2 visits (in-person) at 5 weeks and 4 months from baseline

Trial Site Locations

Total: 1 location

1

CNIB

Toronto, Ontario, Canada, M4G 3E8

Actively Recruiting

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Research Team

M

Monica Daibert-Nido, MD

S

Samuel Markowitz, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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