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

NCT05904444 | Completed

• 1 other identifier: GZAIER2018IRB11
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration; Low Vision; Stargardt Disease

Keywords

Macular disease; low vision; Visual rehabilitation

Outcome Measures

Primary Outcomes (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.

  5 minutes

Secondary Outcomes (3)

• Best corrected visual acuity

  2 minutes

• Reading speed

  3 minutes

• Questionnaires

  10 minutes

Study Arms (2)

daily training

EXPERIMENTAL

Patients underwent microperimetric training on everyday

Procedure: microperimetric biofeedback training

alternately training

EXPERIMENTAL

Patients underwent microperimetric training on every other day

Procedure: microperimetric biofeedback training

Interventions

microperimetric biofeedback training PROCEDURE

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.

alternately training; daily training

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aier Eye Hospital, Guangzhou: lead

Study Sites (1)

MAIA microperimetry

Guangzhou, Guangdong, 510000, China

Location

Related Publications (10)

• 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.

  PMID: 34803584 RESULT

• 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.

  PMID: 25104651 RESULT

• 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.

  PMID: 31266057 RESULT

• 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.

  PMID: 9111255 RESULT

• 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.

  PMID: 29311565 RESULT

• 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.

  PMID: 28930518 RESULT

• 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.

  PMID: 31583549 RESULT

• 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.

  PMID: 33073619 RESULT

• 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.

  PMID: 26265646 RESULT

• 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.

  PMID: 35196835 RESULT

MeSH Terms

Conditions

Macular Degeneration; Vision, Low; Stargardt Disease

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jinling Zhang, doctor

  Aier Eye Hospital, Guangzhou

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: August 15, 2018
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

CN (1)