ClinicalTrials.Veeva

Menu

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

A

Aier Eye Hospital, Guangzhou

Status

Completed

Conditions

Low Vision
Macular Degeneration
Stargardt Disease

Treatments

Procedure: microperimetric biofeedback training

Study type

Interventional

Funder types

Other

Identifiers

NCT05904444
GZAIER2018IRB11

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

All

Ages

12 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

29 participants in 2 patient groups

daily training
Experimental group
Description:
Patients underwent microperimetric training on everyday
Treatment:
Procedure: microperimetric biofeedback training
alternately training
Experimental group
Description:
Patients underwent microperimetric training on every other day
Treatment:
Procedure: microperimetric biofeedback training

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems