Design and Clinical Evaluation of a Smartphone-based Low Vision Enhancement System

The study will employ a single center, randomized crossover design with a 2-week trial period
before the crossover, a 22-week washout period, and a 2-week trial period after the cross
over. Once recruited patients have consented to participate in eligibility screening for the
study, participants will be administered the Activity Inventory (AI), a rating scale
questionnaire about the difficulty of performing a wide range of daily activities and the
Telephone Interview for Cognitive Status (TICS) Eligible patients who consent to participate
will be randomized to Group A or Group B. Group A will be trained to use and will employ at
home for the first 2-week trial period, the headset with the new LVES 2 features and
specifications and then, after the 22-week washout period, will be trained to use and employ
at home for the second 2-week trial period the headset with currently available features and
specifications ("legacy system"). The order will be reversed for Group B who will start with
the legacy system for trial period 1 and then switch to the new LVES 2 system for trial
period 2 after the 22-week washout.

Prior to each 2-week trial period, participants will visit the laboratory and will be taught
how to operate the new LVES 2. Once the participant is familiar with the basic control
operations, he/she will receive one on one instruction from a low vision rehabilitation
therapist on the use of the device with the features and specifications to be tested to
perform distance, intermediate and near activities. Prior to dispensing either device for a
2-week home trial evaluation, the patient must demonstrate to the satisfaction of the
therapist a basic knowledge of and successful operational skill with the device, including an
understanding that participants are not to attempt to walk or operate a vehicle while wearing
the device.

Guided by the AI results, participants will be instructed on the types of activities
participants should perform at home while using the device. The participant will also take
part in baseline testing in 1. Facial recognition, 2.Visual motor test, 3. The International
Reading Speed Texts (IReST) to assess reading performance, and 4. a modified Timed Activity
of Daily Living (TIADL) performance test. The patient will be called during the 2-week home
trial period and a Simulator Sickness Questionnaire (SSQ) will be administered. A follow-up
AI will be administered at the end of the 2-week trial. The participant will return the
headset to the laboratory after the 2-week trial and will be debriefed on participant's
experiences and impressions. The 4 tests will be repeated at this visit (Facial recognition,
Visual motor, IReST and TIADL). None of these procedures are part of or substitute for the
patient's routine care. Investigators will employ rolling enrollment of participants on
staggered schedules. Investigators expect to complete the 50th participant with the first
condition in 22 weeks and then Investigators will start the crossover phase after the 22-week
washout. Investigators expect to complete both phases with the first 50 patients (less drop
outs) in year 1. Investigators then repeat the procedure with the next group of 50
participants in year 2, using systems that include new software features developed in
response to participant feedback.

A treatment success is defined as an improvement in functional ability measured with the
Activity Inventory that exceeds the 95% confidence interval of the estimated baseline measure
[i.e.,Minimum Clinically Important Difference (MCID)]. Stopping the home trial will not be
initiated by the investigators, but participants who are experiencing significant simulator
sickness will be encouraged to stop.

Participants who stop the home trial prematurely will still be asked to complete the
post-trial debriefing and the follow-up AI. Since study participation does not substitute for
the patient's regular clinical care, there is no consequence to the patient for prematurely
ending study participation.

Inclusion Criteria:

- Visual acuity in the better-seeing eye 20/100-20/800

- Horizontal visual field extent >70 degrees diameter, vertical visual field extent >50
degrees.

- Indicate at least 2 goals from the Activity Inventory during the initial screening
interview.

- Scores at least 27 in the Telephone Interview Cognitive Status during the initial
screening interview

Exclusion Criteria:

- Patients who are planning ocular surgery (including laser surgery) during the period
of study participation or are early in anti-neovascular treatment (<6 injections)

- Younger than 14 years of age

- Unable to participate in a telephone interview

- Indicate less than 2 goals from the Activity Inventory

- Score less than 27 in the Telephone Interview Cognitive Status