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

Not Applicable
Completed
Conditions
Stargardt Disease
Low Vision
Macular Degeneration
Interventions
Procedure: microperimetric biofeedback training
Registration Number
NCT05904444
Lead Sponsor
Aier Eye Hospital, Guangzhou
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
29
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
alternately trainingmicroperimetric biofeedback trainingPatients underwent microperimetric training on every other day
daily trainingmicroperimetric biofeedback trainingPatients underwent microperimetric training on everyday
Primary Outcome Measures
NameTimeMethod
fixation stability5 minutes

An index for evaluating macular disease, defined as the accuracy of a patient's gaze at a target over a period of time.

Secondary Outcome Measures
NameTimeMethod
Best corrected visual acuity2 minutes

The most important indicator of visual function, refers to the function of distinguishing objects in the state of refractive correction.

Reading speed3 minutes

One of the indicators for evaluating reading ability, which refers to the number of words within a certain period of time when reading

Questionnaires10 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.

Trial Locations

Locations (1)

MAIA microperimetry

🇨🇳

Guangzhou, Guangdong, China

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