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

Sponsor
Aier Eye Hospital, Guangzhou (Other)
Overall Status
Completed
CT.gov ID
NCT05904444
Collaborator
(none)
29
1
2
56.5
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: microperimetric biofeedback training
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Duration Between Sessions on Microperimetric Biofeedback Training in Patients With Maculopathies
Actual Study Start Date :
Aug 15, 2018
Actual Primary Completion Date :
Apr 30, 2023
Actual Study Completion Date :
Apr 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. fixation stability [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.

Secondary Outcome Measures

  1. Best corrected visual acuity [2 minutes]

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

  2. Reading speed [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. Questionnaires [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MAIA microperimetry Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Aier Eye Hospital, Guangzhou

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie Zhou, Resident doctor, Aier Eye Hospital, Guangzhou
ClinicalTrials.gov Identifier:
NCT05904444
Other Study ID Numbers:
  • GZAIER2018IRB11
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jie Zhou, Resident doctor, Aier Eye Hospital, Guangzhou
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023