MedTrace Logo

Biofeedback in Idiopathic Infantile Nystagmus Syndrome

NCT04142307 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-01

No results posted yet for this study

Summary

Active eye movement control training, an old and still most prevalent intervention in low vision rehabilitation (LVR) was never used in nystagmus clinically.

Biofeedback training (BT) is the latest and newest technique for oculomotor control training in cases with low vision when using available modules in the new microperimetry instruments. Laboratory studies in the literature highlighted positive benefits from using BT in nystagmus cases. The purpose of this study is to assess systematically the impact of BT in a series of cases with Infantile Idiopathic Nystagmus (IIN) and formulate guidelines for further use of this intervention in nystagmus cases in general.

Conditions

  • Low Vision in Children

Interventions

DEVICE

Biofeedback Training

Microperimeter biofeedback training as described provides to the patient a variable frequency sound and a luminous stimulus that vary according to the eyes position, thus guides the oculomotor control and fixation stability accordingly.

DEVICE

Sham - simulated BT

The simulated biofeedback training for Group B involves the following: each session includes 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.

Sponsors & Collaborators

  • Monica Daibert Nido

    lead OTHER

Principal Investigators

  • Samuel Markowitz, MD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2025-04-29
Completion
2027-12-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04142307 on ClinicalTrials.gov