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Biofeedback in Idiopathic Infantile Nystagmus Syndrome

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ClinicalTrials.gov Identifier: NCT04142307
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Monica Daibert Nido, University of Toronto

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.


Condition or disease Intervention/treatment Phase
Low Vision in Children Device: Biofeedback Training Device: Sham - simulated BT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective randomized controlled parallel group study ratio 1:1.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biofeedback in Idiopathic Infantile Nystagmus Syndrome
Actual Study Start Date : January 30, 2019
Actual Primary Completion Date : October 15, 2019
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.

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.




Primary Outcome Measures :
  1. 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) ]
    Measured with the ETDRS charts at 4 m

  2. 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) ]
    Represents the area used for fixation on the retina in square degrees as given by the microperimeter


Secondary Outcome Measures :
  1. Changes in Contrast Sensitivity for near vision across BT sessions and post BT [ Time Frame: 35 days from baseline (V6), and 118 days from baseline (V7) ]
    Two contrast Colenbrander chart

  2. Changes in Stereopsis for near vision across BT and post BT [ Time Frame: 35 days from baseline (V6), and 118 days from baseline (V7) ]
    Frisby Stereotest for near with best near correction

  3. Changes in Quality of Life Parental Questionnaire across BT and post BT [ Time Frame: 35 days from baseline (V6), and 118 days from baseline (V7) ]
    Quality of Life estimates will be assessed with the children's visual function questionnaire (CVFQ).(16)

  4. Changes in Reading speed across BT sessions and post BT [ Time Frame: 35 days from baseline (V6), and 118 days from baseline (V7) ]
    Using the MNRead Test with the best near correction



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142307


Contacts
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Contact: Monica Daibert-Nido, MD 4164819995 monica.nido@uhn.com
Contact: Samuel Markowitz, MD 4164819995

Locations
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Canada, Ontario
CNIB Recruiting
Toronto, Ontario, Canada, M4G 3E8
Contact: Monica Daibert-Nido, MD    416 481 9995    monica.nido@uhn.ca   
Sponsors and Collaborators
Monica Daibert Nido
Investigators
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Principal Investigator: Samuel Markowitz, MD University of Toronto
Publications:
Wang ZI MS, Dell'Osso LF , Ph.D. A Review of the Tenotomy Nystagmus Surgery: Origin, Mechanism, and General Efficacy. Neuro-Ophthalmology, 31:157-165, 2007 ISSN: 0165-8107 DOI: 10.1080/01658100701647704

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Responsible Party: Monica Daibert Nido, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT04142307    
Other Study ID Numbers: Biofeedback Low Vision
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Monica Daibert Nido, University of Toronto:
biofeedback
vision rehabilitation
nystagmus
paediatric
Additional relevant MeSH terms:
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Vision, Low
Nystagmus, Pathologic
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Ocular Motility Disorders
Cranial Nerve Diseases