Visual Telerehabilitation in AMD Patients

Not Applicable

Terminated

• Conditions: Macular Degeneration
• Interventions: Device: Biofeedback Training; Device: Immersive Virtual-Reality

• Registration Number: NCT04685824
• Lead Sponsor: Michael Reber

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Study Start: 2021-09-15
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback Training + Immersive VR	Biofeedback Training	* Biofeedback training (BFT) \[1 sessions of 4 x 20 minutes blocks. Rest time of 5 minutes between blocks\], 1 session per week for 4 weeks (4 sessions total). * 30 min daily reading at home for 4 weeks * Immersive virtual-reality stimulation (IVR) \[1 session of 3 blocks of 15 trials of 20 seconds each. Rest time is 1-2 minute(s) between blocks\], 1 session every 2 days for 4 weeks (14 sessions total).
Biofeedback Training	Biofeedback Training	* Biofeedback training (BFT): 1 sessions of 4 x 20 minutes blocks. Rest time of 5 minutes between blocks. 1 session per week for 4 weeks (4 sessions total). * 30 min daily reading at home for 4 weeks.
Biofeedback Training + Immersive VR	Immersive Virtual-Reality	* Biofeedback training (BFT) \[1 sessions of 4 x 20 minutes blocks. Rest time of 5 minutes between blocks\], 1 session per week for 4 weeks (4 sessions total). * 30 min daily reading at home for 4 weeks * Immersive virtual-reality stimulation (IVR) \[1 session of 3 blocks of 15 trials of 20 seconds each. Rest time is 1-2 minute(s) between blocks\], 1 session every 2 days for 4 weeks (14 sessions total).

Primary Outcome Measures

Name	Time	Method
Feasibility of home-based IVR audiovisual stimulation	18 months	Feasibility objectives for our pilot study to be considered successful: 1. Number of patients completing the stimulation protocol: ≥ 13 out of 16 patients (81%) per group.; 2. Number of IVR sessions performed by the patients to consider the stimulation protocol complete: ≥ 13 sessions out of 16 (81%).; 3. Number of consecutive virtual-reality induced symptoms and effects (VRISE) scores \< 25: ≤ 3 per patient during the treatment period.; 4. Number of patient drop-outs due to cybersickness (discomfort symptoms experienced in VR): ≤ 3 (19%) during the treatment period.; 5. Number of randomized patients per week: ≥ 3 patients.

Secondary Outcome Measures

Name	Time	Method
Fixation stability	from baseline to end of follow-up at 7 months	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)
Reading Speed	from baseline to end of follow-up at 7 months	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)
Visual Acuity	from baseline to end of follow-up at 7 months	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)
Retinal Sensitivity	from baseline to end of follow-up at 7 months	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)
Contrast Sensitivity	from baseline to end of follow-up at 7 months	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)
Quality of Life Scores	from baseline to end of follow-up at 7 months	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)

Trial Locations

Locations (1)

Krembil Research Institute/Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada