Visual Telerehabilitation in AMD Patients

Michael Reber16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Macular Degeneration

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Feasibility of home-based IVR audiovisual stimulation

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.

Time frame: 18 months

Secondary Outcomes

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)