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

Primary Purpose

Macular Degeneration, Low Vision, Stargardt Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
microperimetric biofeedback training
Sponsored by
Aier Eye Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Macular disease, low vision, Visual rehabilitation

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • MAIA microperimetry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

daily training

alternately training

Arm Description

Patients underwent microperimetric training on everyday

Patients underwent microperimetric training on every other day

Outcomes

Primary Outcome Measures

fixation stability
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

Best corrected visual acuity
The most important indicator of visual function, refers to the function of distinguishing objects in the state of refractive correction.
Reading speed
One of the indicators for evaluating reading ability, which refers to the number of words within a certain period of time when reading
Questionnaires
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.

Full Information

First Posted
June 6, 2023
Last Updated
June 6, 2023
Sponsor
Aier Eye Hospital, Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT05904444
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aier Eye Hospital, Guangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Low Vision, Stargardt Disease
Keywords
Macular disease, low vision, Visual rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
daily training
Arm Type
Experimental
Arm Description
Patients underwent microperimetric training on everyday
Arm Title
alternately training
Arm Type
Experimental
Arm Description
Patients underwent microperimetric training on every other day
Intervention Type
Procedure
Intervention Name(s)
microperimetric biofeedback training
Intervention Description
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.
Primary Outcome Measure Information:
Title
fixation stability
Description
An index for evaluating macular disease, defined as the accuracy of a patient's gaze at a target over a period of time.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Description
The most important indicator of visual function, refers to the function of distinguishing objects in the state of refractive correction.
Time Frame
2 minutes
Title
Reading speed
Description
One of the indicators for evaluating reading ability, which refers to the number of words within a certain period of time when reading
Time Frame
3 minutes
Title
Questionnaires
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinling Zhang, doctor
Organizational Affiliation
Aier Eye Hospital, Guangzhou
Official's Role
Study Director
Facility Information:
Facility Name
MAIA microperimetry
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34803584
Citation
Maniglia M, Visscher KM, Seitz AR. Perspective on Vision Science-Informed Interventions for Central Vision Loss. Front Neurosci. 2021 Nov 4;15:734970. doi: 10.3389/fnins.2021.734970. eCollection 2021.
Results Reference
result
PubMed Identifier
25104651
Citation
Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. doi: 10.1016/S2214-109X(13)70145-1. Epub 2014 Jan 3.
Results Reference
result
PubMed Identifier
31266057
Citation
Wang Y, Ye J, Shen M, Yao A, Xue A, Fan Y, Huang S, Wang J, Lu F, Shao Y. Photoreceptor Degeneration is Correlated With the Deterioration of Macular Retinal Sensitivity in High Myopia. Invest Ophthalmol Vis Sci. 2019 Jul 1;60(8):2800-2810. doi: 10.1167/iovs.18-26085.
Results Reference
result
PubMed Identifier
9111255
Citation
Fletcher DC, Schuchard RA. Preferred retinal loci relationship to macular scotomas in a low-vision population. Ophthalmology. 1997 Apr;104(4):632-8. doi: 10.1016/s0161-6420(97)30260-7.
Results Reference
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PubMed Identifier
29311565
Citation
Maniglia M, Soler V, Cottereau B, Trotter Y. Spontaneous and training-induced cortical plasticity in MD patients: Hints from lateral masking. Sci Rep. 2018 Jan 8;8(1):90. doi: 10.1038/s41598-017-18261-6.
Results Reference
result
PubMed Identifier
28930518
Citation
Vingolo EM, Napolitano G, Fragiotta S. Microperimetric biofeedback training: fundamentals, strategies and perspectives. Front Biosci (Schol Ed). 2018 Jan 1;10(1):48-64. doi: 10.2741/s500.
Results Reference
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PubMed Identifier
31583549
Citation
Morales MU, Saker S, Wilde C, Rubinstein M, Limoli P, Amoaku WM. Biofeedback fixation training method for improving eccentric vision in patients with loss of foveal function secondary to different maculopathies. Int Ophthalmol. 2020 Feb;40(2):305-312. doi: 10.1007/s10792-019-01180-y. Epub 2019 Oct 3.
Results Reference
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PubMed Identifier
33073619
Citation
Sahli E, Altinbay D, Bingol Kiziltunc P, Idil A. Effectiveness of Low Vision Rehabilitation Using Microperimetric Acoustic Biofeedback Training in Patients with Central Scotoma. Curr Eye Res. 2021 May;46(5):731-738. doi: 10.1080/02713683.2020.1833348. Epub 2020 Oct 18.
Results Reference
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PubMed Identifier
26265646
Citation
Raman R, Damkondwar D, Neriyanuri S, Sharma T. Microperimetry biofeedback training in a patient with bilateral myopic macular degeneration with central scotoma. Indian J Ophthalmol. 2015 Jun;63(6):534-6. doi: 10.4103/0301-4738.162609.
Results Reference
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PubMed Identifier
35196835
Citation
Bozkurt Oflaz A, Turgut Ozturk B, Gonul S, Bakbak B, Gedik S, Okudan S. Short-Term Clinical Results of Preferred Retinal Locus Training. Turk J Ophthalmol. 2022 Feb 23;52(1):14-22. doi: 10.4274/tjo.galenos.2021.73368.
Results Reference
result

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

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