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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05904444
• Other study ID #: GZAIER2018IRB11
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2023
• Source: Aier Eye Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Low Vision
• Macular Degeneration
• Stargardt Disease
• Vision, Low

Intervention

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.

Locations

Country	Name	City	State
China	MAIA microperimetry	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Aier Eye Hospital, Guangzhou

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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. Epu — View 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. — View 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/io — View 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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Best corrected visual acuity	The most important indicator of visual function, refers to the function of distinguishing objects in the state of refractive correction.	2 minutes
Secondary	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	3 minutes
Secondary	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.	10 minutes