Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05904444
Enrollment
29
Registered
2023-06-15
Start date
2018-08-15
Completion date
2023-04-30
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Vision, Macular Degeneration, Stargardt Disease

Keywords

Macular disease, low vision, Visual rehabilitation

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.

Interventions

PROCEDUREmicroperimetric 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.

Sponsors

Aier Eye Hospital, Guangzhou
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
fixation stability5 minutesAn index for evaluating macular disease, defined as the accuracy of a patient's gaze at a target over a period of time.

Secondary

MeasureTime frameDescription
Best corrected visual acuity2 minutesThe most important indicator of visual function, refers to the function of distinguishing objects in the state of refractive correction.
Reading speed3 minutesOne of the indicators for evaluating reading ability, which refers to the number of words within a certain period of time when reading
Questionnaires10 minutesQuestionnaires 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026