Clinical trial NCT03728660: Design and Clinical Evaluation of a Smartphone-based Low Vision Enhancement System
Official title: Design and Clinical Evaluation of a Smartphone-based Low Vision Enhancement System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Vision
Keywords: age related macular degeneration
visual impairment
virtual reality
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: Visionize, LLC
First posted: 2018-11-02
Enrollment: 88
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intention to treat design; crossover with 22 week washout period between interventions; primary outcome measure is patient-reported function
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective is to compare the effectiveness and adverse side-effects of the virtual bioptic telescope and virtual projection screen in a new head-mounted video-based low vision enhancement system (LVES) with a wide field of view to currently employed specifications for head-mounted video display low vision enhancement technology. Secondary objectives are to acquire qualitative information from patients to evaluate the functioning of the system, to optimize system features and operations, and to assess the value patients place on system features, functions, and operating parameters relative to those of current technology. Investigators will conduct a comparative effectiveness study to determine if the novel vision enhancing features of LVES 2 provide low vision patients with benefits superior to those provided by existing technology.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Visual acuity in the better-seeing eye 20/60-20/800
* 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

Primary outcomes:
measure: Mean change in patients' self-reported functional ability as assessed by the Activity Inventory (AI) rating scale questionnaire
timeFrame: 2 weeks, 24 weeks
Secondary outcomes:
measure: Minimum Clinically Important Difference (MCID) in patient's self-reported functional ability estimated from difficulty ratings of activities in the AI rating scale questionnaire
timeFrame: 2 weeks, 24 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert W Massof, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deemer AD, Bradley CK, Ross NC, Natale DM, Itthipanichpong R, Werblin FS, Massof RW. Low Vision Enhancement with Head-mounted Video Display Systems: Are We There Yet? Optom Vis Sci. 2018 Sep;95(9):694-703. doi: 10.1097/OPX.0000000000001278.
citation: Goldstein JE, Jackson ML, Fox SM, Deremeik JT, Massof RW; Low Vision Research Network Study Group. Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers. JAMA Ophthalmol. 2015 Jul;133(7):762-9. doi: 10.1001/jamaophthalmol.2015.0693.
citation: Massof RW, Ahmadian L, Grover LL, Deremeik JT, Goldstein JE, Rainey C, Epstein C, Barnett GD. The Activity Inventory: an adaptive visual function questionnaire. Optom Vis Sci. 2007 Aug;84(8):763-74. doi: 10.1097/OPX.0b013e3181339efd.