The Effect of Duration Between Sessions on Microperimetric Biofeedback Training in Patients With Maculopathies

Study Overview
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Brief Summary
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Patients who develop macular diseases have several clinical complications,such as central vision loss, the central scotoma of the visual field, the decrease of reading speed and fixation stability. At present, there is still no satisfactory effect in the prevention and treatment of advanced macular disease. A new rehabitation strategy named microperimetric biofeedback training has been shown to be effective in improving patients' visual appearance, but there is no consensus regarding the optimal methodology and standard of practice. Therefore, we designed a prospective clinical study to verify the effectiveness of MBFT and to determine an optimal plan.

Detailed Description
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The present study aimed to investigate the effects of training frequency and number of training sessions on the visual outcomes of patients with various macular diseases. A total of 15 training sessions were conducted on two distinct frequencies, namely once a day and once every other day. Baseline measurements included fixation stability, reading speed, and best corrected visual acuity (BCVA) were obtained and followed up after the 5, 10, and 15 training sessions. By comparing the changes in these visual function parameters across different stages of training, the study aimed to identify and analyze the underlying patterns and rules governing the training process. Ultimately, the results of this study could serve as a valuable reference for standardizing the use of MBFT in clinical practice.

Official Title
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The Effect of Duration Between Sessions on Microperimetric Biofeedback Training in Patients With Maculopathies

Conditions
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Macular Degeneration, Low Vision, Stargardt Disease

Intervention / Treatment
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* Procedure: microperimetric biofeedback training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants who (1) were diagnosed with macular disease and had a BCVA poorer than 20/60; (2) with stable fundus lesion in fundus examinations; (3)with education level beyond the third grade; (4)had no other effective treatment; and (5)were willing to improve visual quality. Exclusion Criteria: who (1) received ocular treatments in the preceding 3 months, (2) with active fundus lesions like inflammation, bleeding, exudation, edema, (3) with obvious opacity of the refractive media such as keratopathy, severe cataract, or severe vitreous opacity, (4) were unable to attend scheduled follow-up appointments.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: daily training<br>Patients underwent microperimetric training on everyday | Procedure: microperimetric biofeedback training<br>* Microperimetry biofeedback training is a noninvasive stragegy to develop a new trained retinal locus or strength the spontaneous preferred retinal locus to get better visual performances.The rationale of MBFT consists in reeducating visual system to a new visual condition, promoting retina-brain transmission, and further enhancing synaptic plasticity and neural capacity by acoustic biofeedback or structured light stimulus biofeedback.<br>|
| Experimental: alternately training<br>Patients underwent microperimetric training on every other day | Procedure: microperimetric biofeedback training<br>* Microperimetry biofeedback training is a noninvasive stragegy to develop a new trained retinal locus or strength the spontaneous preferred retinal locus to get better visual performances.The rationale of MBFT consists in reeducating visual system to a new visual condition, promoting retina-brain transmission, and further enhancing synaptic plasticity and neural capacity by acoustic biofeedback or structured light stimulus biofeedback.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fixation stability | An index for evaluating macular disease, defined as the accuracy of a patient's gaze at a target over a period of time. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | The most important indicator of visual function, refers to the function of distinguishing objects in the state of refractive correction. | 2 minutes | 
| Reading speed | One of the indicators for evaluating reading ability, which refers to the number of words within a certain period of time when reading | 3 minutes | 
| Questionnaires | Questionnaires were used to determine the influence of eye symptoms and visual impairment on daily life attributed to the limitation of patients' social function and activities. | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular disease, low vision, Visual rehabilitation