Recruiting

Biofeedback

Sponsor:

Monica Daibert Nido

Code:

NCT04142307

Conditions

Low Vision in Children

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Biofeedback Training

Sham - simulated BT

Study Details

Brief 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

Study ID

NCT04142307

Start date

Jan 30, 2019

Status verified date

Apr, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Apr 29, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed as Infantile idiopathic nystagmus (IIN)
  • Ability to follow the visual and auditory stimuli and training instructions

Exclusion Criteria:

  • Ocular diseases not related to the nystagmus physiopathology
  • Both eyes with media opacity that impairs microperimetry testing
  • Peripheral nystagmus cases
  • Other types of nystagmus than IIN
  • Inability to perform during testing and training

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A (treatment)

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.

sham comparator: Group B (control)

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.

Interventions

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.

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.

Primary outcome measure

  • Changes in Best Corrected Visual Acuity for Distance Vision across BT sessions and post BT [ Time Frame: 7 days from baseline (V2), 14 days (V3), 21 days (V4), 28 days (V5), 35 days (V6), and 118 days from baseline (V7) ]
  • Changes in Fixation Stability (Bivariate contour ellipse area) across BT sessions and post BT [ Time Frame: 7 days from baseline (V2), 14 days (V3), 21 days (V4), 28 days (V5), 35 days (V6), and 118 days from baseline (V7) ]

Central Contacts and Locations

Central contacts

Monica Daibert-Nido, MD

4164819995monica.nido@uhn.com

Samuel Markowitz, MD

4164819995

Locations

CNIB

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Contacts

Monica Daibert-Nido, MD

416 481 9995monica.nido@uhn.ca

More Information

Sponsor

Monica Daibert Nido

Last update posted

May 1, 2025

Last verified

Apr, 2025

Keywords

  • biofeedback
  • vision rehabilitation
  • nystagmus
  • paediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Monica Daibert Nido on 2025-05-01.