← Back to Search

Behavioural Intervention

Biofeedback for Nystagmus

N/A

Recruiting

Led By Samuel Markowitz, MD

Research Sponsored by Monica Daibert Nido

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days from baseline (v2), 14 days (v3), 21 days (v4), 28 days (v5), 35 days (v6), and 118 days from baseline (v7)

Awards & highlights

Study Summary

This trial assesses the impact of BT in a series of cases with Infantile Idiopathic Nystagmus (IIN) and aims to formulate guidelines for further use of this intervention in nystagmus cases in general.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Since this trial involves training rather than medication, traditional side effects are not expected. However, participants may experience fatigue or frustration related to the exercises.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days from baseline (v2), 14 days (v3), 21 days (v4), 28 days (v5), 35 days (v6), and 118 days from baseline (v7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days from baseline (v2), 14 days (v3), 21 days (v4), 28 days (v5), 35 days (v6), and 118 days from baseline (v7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days from baseline (v2), 14 days (v3), 21 days (v4), 28 days (v5), 35 days (v6), and 118 days from baseline (v7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Best Corrected Visual Acuity for Distance Vision across BT sessions and post BT

Changes in Fixation Stability (Bivariate contour ellipse area) across BT sessions and post BT

Secondary outcome measures

Changes in Contrast Sensitivity for near vision across BT sessions and post BT

Changes in Quality of Life Parental Questionnaire across BT and post BT

Changes in Reading speed across BT sessions and post BT

+1 more

Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Monica Daibert NidoLead Sponsor

Samuel Markowitz, MDPrincipal InvestigatorUniversity of Toronto

2 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Biofeedback Training (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04142307 — N/A

Low Vision Research Study Groups: Group A (treatment), Group B (control)

Low Vision Clinical Trial 2023: Biofeedback Training Highlights & Side Effects. Trial Name: NCT04142307 — N/A

Biofeedback Training (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04142307 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the authorization to partake in this investigation?

"To be accepted into this medical trial, applicants must present with a low visual acuity and span the ages of 5 to 17. There are currently 34 participants being recruited."

Answered by AI

What is the estimated enrolment of this trial?

"Affirmative. The details available on clinicaltrials.gov confirm that this medical experiment, listed since January 30th 2019, is actively searching for participants. 34 individuals will be accepted at 1 centre to partake in the study."

Answered by AI

What aims is this investigation attempting to meet?

"The objective of this medical trial, which will be evaluated at intervals including 2 weeks (V3), 4 weeks(V5) and 17 weeks from baseline(V7), is to ascertain any modifications in far-sightedness with binocular therapy sessions and post-binocular treatment. Ancillary outcomes involve gauging variations in near vision acuity through the Colenbrander chart, quality of life by a special questionnaire for children's visual function, along with reading velocity using the MNRead Test for optimum close correction."

Answered by AI

Are participants of this research initiative required to be above the age of majority?

"The parameters for enrollment in this trial indicate a minimum age of 5 and maximum age of 17."

Answered by AI

Are there still openings accessible for individuals to join this study?

"Affirmative. Evidence from clinicaltrials.gov suggests that this research study is actively recruiting participants, having first been posted on January 30th 2019 and most recently updated on March 29th 2022. 34 people are needed to be admitted at a single site for participation in the trial."

Answered by AI

Recent research and studies

Annals of the New York Academy of SciencesJournal

Evaluation of Current Optical Methods for Treating the Visual Consequences of Nystagmus

YANIGLOS, STACY S., JOHN S. STAHL, and R. JOHN LEIGH. 2002. “Evaluation of Current Optical Methods for Treating the Visual Consequences of Nystagmus”. Annals of the New York Academy of Sciences. Wiley. doi:10.1111/j.1749-6632.2002.tb02893.x.

American Journal of OphthalmologyJournal

Development of an Instrument to Assess Vision-related Quality of Life in Young Children

Felius, Joost, David R. Stager Sr, Priscilla M. Berry, Sherry L. Fawcett, David R. Stager Jr, Solange R. Salomão, Adriana Berezovsky, and Eileen E. Birch. 2004. “Development of an Instrument to Assess Vision-related Quality of Life in Young Children”. American Journal of Ophthalmology. Elsevier BV. doi:10.1016/j.ajo.2004.05.010.

Acta Ophthalmologica ScandinavicaJournal

Treatment of Strabismus and Nystagmus with Botulinum Toxin Type A, an Evaluation of Effects and Complications

Lennerstrand, Gunnar, Odd Åsmund Nordbø, Suna Tian, Brigitte Eriksson-Derouet, and Talal Ali. 1998. “Treatment of Strabismus and Nystagmus with Botulinum Toxin Type A, an Evaluation of Effects and Complications”. Acta Ophthalmologica Scandinavica. Wiley. doi:10.1034/j.1600-0420.1998.760106.x.

British Journal of OphthalmologyJournal