Visual Telerehabilitation in AMD Patients

Macular Degeneration Clinical Trial

Official title:

Visual Rehabilitation in Macular Degeneration: a Pilot Study on Biofeedback Training and Home-based Mobile Virtual-reality Stimulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04685824
• Other study ID #: 2020410013068
• Status: Terminated
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: October 6, 2023

Study information

• Verified date: November 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Following the degeneration of the macula and the loss of central vision, the patients naturally relocate the fixation point for high visual acuity peripherally, in an eccentric and healthy part of the retina (PRL), to compensate for visual impairments. However, in many cases, the PRL lands on a sub-optimal retinal area and becomes useless. Modern low-vision rehabilitation procedures for AMD patients include biofeedback training (BFT) to relocate the PRL to a healthy retinal patch and acquire better fixation skills. This study seeks to combine BFT with home-based immersive virtual-reality audiovisual stimulation and measure feasibility and potential effectiveness on oculomotor control and visual perception.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Dry-AMD.

• BCVA > 20/160.

• Ability to follow the visual and auditory stimuli and training instructions.

• Auditory test positive at 50Hz 25-60dBHL.

• Home Wi-Fi access.

Exclusion Criteria:

• Wet AMD.

• Both eyes with media opacity that impairs microperimetry testing.

• Inability to perform during testing and training.

• Psychoactive drugs consumption.

• 3 consecutive VRISE scores < 25 at inclusion.

• History of vertigo or dizziness

• Prior vision rehabilitation interventions.

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Device:
• Biofeedback Training
Audiovisual stimulation
• Immersive Virtual-Reality
Audiovisual stimulation

Locations

Country	Name	City	State
Canada	Krembil Research Institute/Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Michael Reber

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of home-based IVR audiovisual stimulation	Feasibility objectives for our pilot study to be considered successful: Number of patients completing the stimulation protocol: = 13 out of 16 patients (81%) per group.; Number of IVR sessions performed by the patients to consider the stimulation protocol complete: = 13 sessions out of 16 (81%).; Number of consecutive virtual-reality induced symptoms and effects (VRISE) scores < 25: = 3 per patient during the treatment period.; Number of patient drop-outs due to cybersickness (discomfort symptoms experienced in VR): = 3 (19%) during the treatment period.; Number of randomized patients per week: = 3 patients.	18 months
Secondary	Visual Acuity	Change from baseline at 4 weeks, 1 month and 6 months: - Best Corrected Visual Acuity, distance and near vision (range 20/12.5 to <20/1000, higher score = better outcome)	from baseline to end of follow-up at 7 months
Secondary	Retinal Sensitivity	Change from baseline at 4 weeks,1 month and 6 months: - Mean retinal sensitivity (Macular Integrity Assessment, MAIA microperimetry - score: 0 dB to 36 dB, higher score = better outcome)	from baseline to end of follow-up at 7 months
Secondary	Fixation stability	Change from baseline at 4 weeks,1 month and 6 months: - Mean fixation stability (Macular Integrity Assessment, MAIA microperimetry - range 0.02 sq.deg. to 40.0 sq.deg., lowest score = better outcome)	from baseline to end of follow-up at 7 months
Secondary	Contrast Sensitivity	Change from baseline at 4 weeks, 1 month and 6 months: - Mean contrast sensitivity (Functional Acuity Contrast Test, FACT - range 0.48 cyc./deg. to 2.41 cyc./deg., higher score = better outcome)	from baseline to end of follow-up at 7 months
Secondary	Reading Speed	Change from baseline at 4 weeks,1 month and 6 months: - Mean reading speed (Minnesota Low Vision Reading test, MNREAD - range 0 word/minute to 280 word/minute, higher score = better outcome)	from baseline to end of follow-up at 7 months
Secondary	Quality of Life Scores	Change from baseline at 4 weeks,1 month and 6 months: - Quality of life scores (Veteran's Affairs Low Vision Questionnaire, VA-LVQ 48 - range -31.5 to +26.6, higher score = better outcome)	from baseline to end of follow-up at 7 months