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

June 6, 2023 updated by: Jie Zhou, Aier Eye Hospital, Guangzhou
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • MAIA microperimetry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: daily training
Patients underwent microperimetric training on everyday
Procedure: microperimetric biofeedback training
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.
Experimental: alternately training
Patients underwent microperimetric training on every other day
Procedure: microperimetric biofeedback training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fixation stability
Time Frame: 5 minutes
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
Time Frame: 2 minutes
The most important indicator of visual function, refers to the function of distinguishing objects in the state of refractive correction.
2 minutes
Reading speed
Time Frame: 3 minutes
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
Time Frame: 10 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aier Eye Hospital, Guangzhou

Investigators

  • Study Director: Jinling Zhang, doctor, Aier Eye Hospital, Guangzhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZAIER2018IRB11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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