Clinical trial NCT05904444: The Effect of Duration Between Sessions on Microperimetric Biofeedback Training in Patients With Maculopathies
Official title: The Effect of Duration Between Sessions on Microperimetric Biofeedback Training in Patients With Maculopathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration
Low Vision
Stargardt Disease
Keywords: Macular disease
low vision
Visual rehabilitation
Lead sponsor: Aier Eye Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: fixation stability
timeFrame: 5 minutes
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 2 minutes
measure: Reading speed
timeFrame: 3 minutes
measure: Questionnaires
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: MAIA microperimetry
state: Guangdong
Study officials:
affiliation: Aier Eye Hospital, Guangzhou
name: Jinling Zhang, doctor
role: STUDY_DIRECTOR
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