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Macular DegenerationNCT05904444

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

A study testing microperimetric biofeedback training in people with Macular Degeneration and Low Vision, run by Aier Eye Hospital, Guangzhou at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 80 years
What is being tested?
microperimetric biofeedback training
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
15 Aug 2018to 30 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • MAIA microperimetry

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

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.

Read the 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.

Being tested
microperimetric biofeedback training
Keywords
Macular disease, low vision, Visual rehabilitation
Medical subject headings
Macular Degeneration, Vision, Low, Stargardt Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • microperimetric biofeedback trainingProcedure or surgery

    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.

Study groups in NCT05904444
Study groupRoleWhat they receive
daily trainingExperimentalPatients underwent microperimetric training on everyday
Receives: Procedure: microperimetric biofeedback training
alternately trainingExperimentalPatients underwent microperimetric training on every other day
Receives: Procedure: microperimetric biofeedback training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 minutes

Secondary outcomes (3)

  1. Best corrected visual acuity

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

    Measured: 2 minutes

  2. 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

    Measured: 3 minutes

  3. 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.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start15 Aug 2018
  3. Primary completion30 Apr 2023
  4. Study completion30 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05904444
Sponsor's protocol ID
GZAIER2018IRB11
Status last verified
Jun 2023
First submitted
6 Jun 2023
Last updated
15 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34803584

  • 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.

    PubMed 25104651

  • 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.

    PubMed 31266057

  • 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.

    PubMed 9111255

  • 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.

    PubMed 29311565

  • 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.

    PubMed 28930518

  • 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.

    PubMed 31583549

  • 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.

    PubMed 33073619

  • 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.

    PubMed 26265646

  • 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.

    PubMed 35196835

Questions about this trial

What is this clinical trial studying?

A study testing microperimetric biofeedback training in people with Macular Degeneration and Low Vision, run by Aier Eye Hospital, Guangzhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fixation stability (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05904444, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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