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临床试验/NCT04142307
NCT04142307招募中不适用

Biofeedback in Idiopathic Infantile Nystagmus Syndrome

Monica Daibert Nido2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
34
试验地点
2
主要终点
Changes in Best Corrected Visual Acuity for Distance Vision across BT sessions and post BT

研究概览

简要总结

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.

详细描述

Background:

Infantile idiopathic nystagmus (IIN) or congenital motor nystagmus is most common among infantile nystagmus cases. It has a characteristic waveform eye movement pattern with an exponentially increasing velocity slow-phase followed by a saccadic fast phase.

IIN is present from infancy but usually recognized few months into life and may even be evident only after the child has reached several years of age. Characteristics of IIN include the following: conjugate eye movements with equal frequency and amplitude in each eye, gaze position does not change the direction of fast phase, a null point may be present with less motor instability, convergence achieves better motor stability, head turn and head tilt present to facilitate viewing at null point and absence of oscillopsia in most cases.

When the patient is asymptomatic no treatment is required. However, if the visual acuity is decreased with abnormal head posture and oscillopsia interventions are warranted.

Traditional used therapies include muscle surgery, optical devices, drugs and botulinum toxin injections. All current available therapies aim at changing the functional balance among eye muscles responsible for eye movements with hope that they will produce better ocular stability and better foveation time for incoming images with better vision. All such cases also require Low Vision Rehabilitation interventions to improve functional vision and Quality of Life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

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

时间窗: 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

次要结局

  • Changes in Contrast Sensitivity for near vision across BT sessions and post BT(35 days from baseline (V6), and 118 days from baseline (V7))
  • Changes in Stereopsis for near vision across BT and post BT(35 days from baseline (V6), and 118 days from baseline (V7))
  • Changes in Quality of Life Parental Questionnaire across BT and post BT(35 days from baseline (V6), and 118 days from baseline (V7))
  • Changes in Reading speed across BT sessions and post BT(35 days from baseline (V6), and 118 days from baseline (V7))

研究者

发起方
Monica Daibert Nido
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Monica Daibert Nido

Assistant Professor

University of Toronto

研究点 (2)

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